Prometra Intrathecal Catheter 11823Recalls & reported problems

Summary

The FDA's MAUDE database contains 322 adverse event reports that list this exact device (DI 00810335020099), received between Sep 18, 2015 and Oct 17, 2023 — classified as 1 death, 291 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Migration” (71 reports).

13 other recalls cover devices cleared under the same FDA submission (P080012); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 322 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2023Insufficient Flow or Under Infusion; Migration; Insufficient Flow or Under Infusion; Migration

  PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL REPORTING A CATHETER REVISION DUE TO CATHETER MIGRATION. THE PATIENT WAS REPORTED TO HAVE A LACK OF PAIN RELIEF AND HAD VOLUME DISCREPANCIES OBSERVED AT THEIR LAST FOUR REFILL APPOINTMENTS. A CATHETER DYE STUDY WAS PERFORMED AND IT WAS DETERMINED THAT THE CATHETER WAS SHOWN TO BE PULLED OUT OF THE INTRATHECAL SPACE. THE PATIENT HAD REPORTED A PREVIOUS FALL, BUT COULD NOT RECALL WHEN IT WAS. THE PATIENT'S OLD CATHETER WAS DISCARDED AFTER THE SURGERY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17954040 ↗
• InjuryAug 14, 2023Migration; Migration

  PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL REPORTING A CATHETER REPLACEMENT SURGERY. THE REASON FOR REPLACEMENT WAS STATED TO BE CATHETER MIGRATION WITH A LOSS OF THERAPY. THE CATHETER WAS DISCARDED AFTER SURGERY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17539874 ↗
• InjuryJun 29, 2023Fracture; Obstruction of Flow; Fracture; Obstruction of Flow

  AGENT COVERING THE ISSUE RESPONDED WITH ADDITIONAL INFORMATION. AGENT REPORTED THAT THE PHYSICIAN DECIDED TO REPLACE THE PATIENT'S PUMP DUE TO THE PUMP'S AGE. THE PHYSICIAN ALSO DECIDED TO REPLACE THE PATIENT'S CATHETER AS IT WAS SEVERED ABOVE THE ANCHOR POSITION. AGENT REPORTED THAT A NEW PUMP AND CATHETER WERE IMPLANTED AND THE PATIENT IS NOW RECEIVING THERAPY. THE PATIENT'S OLD PUMP AND CATHETER WERE DISCARDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17225709 ↗
• InjuryJun 6, 2023Migration; Migration

  PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH THE MAIL REPORTING A CATHETER REVISION. THE REASON FOR THE REVISION WAS REPORTED TO BE THAT THE CATHETER HAD MIGRATED FROM THE PATIENT'S SPINE. ADDITIONAL COMMUNICATION WITH A REPRESENTATIVE COVERING THE ISSUE CONFIRMED THAT THE PATIENT WAS EXPERIENCING A LACK OF PAIN RELIEF. REPRESENTATIVE STATED THAT THE PHYSICIAN WAS UNABLE TO ASPIRATE ANY CSF FROM THE CATHETER. REPRESENTATIVE STATED THAT WHEN A FLUOROSCOPY EXAM WAS PERFORMED DURING SURGERY, IT APPEARED THAT THE CATHETER WAS NOT IN THE SPINE BUT WAS INSTEAD SUBCUTANEOUS. REPRESENTATIVE STATED THAT WHEN THE SURGEON WITHDREW THE CATHETER FROM THE SPINAL INSERTION POINT, ONLY A SHORT SECTION OF THE COMPLETE CATHETER WAS OBSERVED TO HAVE REMAINED IN THE SPINE. NO OTHER DEVICE ISSUES WERE IDENTIFIED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17071406 ↗
• InjuryMay 15, 2023Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Flow or Under Infusion; Obstruction of Flow

  PATIENT TRACKING RECEIVED A TRACKING FORM IN THE MAIL REPORTING A CATHETER REVISION SURGERY. THE REASON FOR REVISION WAS A CATHETER OCCLUSION. THE REVISED CATHETER WAS DISCARDED. ADDITIONAL COMMUNICATION WITH THE AGENT COVERING THE ISSUE CONFIRMED THAT AN UNDERINFUSION VOLUME DISCREPANCY WAS OBSERVED, THE EXPECTED VOLUME BEING 5ML AND THE ACTUAL ASPIRATED VOLUME BEING 19ML. THE PATIENT ALSO ALLEGED A DECREASE IN THERAPY. A CATHETER DYE STUDY WAS PERFORMED, WHICH IDENTIFIED THE CATHETER OCCLUSION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16931073 ↗
• MalfunctionApr 28, 2023Obstruction of Flow; Obstruction of Flow

  PATIENT'S SPOUSE CONTACTED TECHNICAL SOLUTIONS TO REPORT THAT THE PATIENT BEGAN SEEING A NEW PHYSICIAN RECENTLY FOR PUMP REFILLS. THIS PHYSICIAN REPORTEDLY PERFORMED A CATHETER DYE STUDY ABOUT ONE AND A HALF MONTHS AGO WHICH SHOWED THE PUMP TO BE "BROKEN". THE PATIENT AND THEIR SPOUSE REPORTEDLY DID NOT KNOW WHAT CAUSED THE DYE STUDY TO BE PERFORMED. TECHNICAL SOLUTIONS FOLLOWED UP WITH A LOCAL REPRESENTATIVE FOR MORE INFORMATION. THE AGENT REPORTED THAT THEY HAD ASSISTED THE PHYSICIAN WITH THE CATHETER DYE STUDY AND CONFIRMED THAT THE ISSUE IS CATHETER-RELATED. THE AGENT STATED THAT THEY WERE UNABLE TO ASPIRATE FROM THE CAP DURING THE STUDY, AND THE FLUOROSCOPY WAS UNCLEAR. THE PHYSICIAN DECIDED THAT THE PATIENT'S PUMP SHOULD BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831622 ↗
• InjuryApr 18, 2023Obstruction of Flow; Obstruction of Flow

  PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL REPORTING A CATHETER REPLACEMENT SURGERY. THE REASON FOR REPLACEMENT WAS REPORTED TO BE A NEGATIVE CAP PROCEDURE WHICH INDICATED EITHER A KINK OR OCCLUSION OF SOME KIND IN THE CATHETER. ADDITIONALLY THE PATIENT HAD EXPERIENCED A LACK OF THERAPY. THE REPLACED CATHETER WAS DISCARDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16765338 ↗
• InjuryApr 14, 2023Break; Break

  PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL REPORTING A CATHETER REVISION SURGERY. THE REASON FOR REVISION WAS REPORTED TO BE THAT THE CATHETER HAD BROKEN AT THE ANCHOR POINT. THE REVISED CATHETER SEGMENT WAS DISCARDED. ADDITIONAL COMMUNICATION WITH A CLINICAL SPECIALIST (CS) COVERING THE ISSUE CONFIRMED THAT A MYELOGRAM WAS PERFORMED TO IDENTIFY THE CATHETER BREAK. CS STATED THAT THEY WERE UNAWARE OF ANY FALLS OF TRAUMA FOR THE PATIENT. CS REPORTED THAT THE PATIENT'S PHYSICIAN REPORTED THAT THE PATIENT WAS WITHOUT THERAPY FOR A WHILE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16742772 ↗
• InjuryMar 23, 2023Migration; Migration

  PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL REPORTING A CATHETER REVISION. THE REASON FOR REVISION WAS THAT THE CATHETER HAD MIGRATED OUT OF THE INTRATHECAL SPACE. DEVICE WAS DISCARDED. ADDITIONAL FOLLOW-UP WITH AN AGENT COVERING THE ISSUE CONFIRMED THAT THE PATIENT EXPERIENCED A LACK OF THERAPY. AGENT ALSO REPORTED THAT THE MIGRATION WAS IDENTIFIED THROUGH FLUOROSCOPY. AGENT REPORTED THAT THE CAUSE OF THE CATHETER MIGRATION WAS UNKNOWN.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16598676 ↗
• InjuryMar 1, 2023Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Flow or Under Infusion; Obstruction of Flow

  REPORTER CONTACTED TECHNICAL SOLUTIONS TO REPORT THAT A PATIENT'S PUMP WAS EXPLANTED DUE TO THE DEVICE MALFUNCTIONING. ADDITIONAL INFORMATION WAS PROVIDED, WHICH CONFIRMED THAT A DYE STUDY HAD BEEN PERFORMED IN WHICH THE PHYSICIAN WAS UNABLE TO ASPIRATE FROM THE PUMP. DURING THE EXPLANT PROCEDURE, THE EXPECTED VOLUME OF DRUG IN THE PUMP WAS 16.4ML AND 25ML WAS ABLE TO BE WITHDRAWN FROM THE PUMP. THE PATIENT'S PUMP AND CATHETER WERE REPLACED WITH MEDTRONIC DEVICES.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16459848 ↗
• InjuryJan 31, 2023No Flow; No Flow

  PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL REPORTING A CATHETER REVISION. ADDITIONAL FOLLOW-UP WITH THE AGENT COVERING THE ISSUE VIA PHONE CALL CONFIRMED THAT THE PATIENT HAD BEEN SCHEDULED FOR A REVISION AS THEIR PUMP WAS FLIPPED. PER THE AGENT, "WHEN WE GOT IN, THE CATHETER WAS ALSO NOT PATENT. IT WASN'T KINKED, IT JUST HAD NO FLOW." AGENT REPORTED THAT IT WAS NOT KNOWN WHY THE PUMP FLIPPED AND CONFIRMED THAT THE PUMP HAD BEEN SUTURED DOWN INITIALLY. THE SUTURES WERE REPORTEDLY STILL VISIBLE. THE PUMP REMAINS IMPLANTED, AND THE CATHETER WILL NOT BE RETURNED. PER THE AGENT, "WE TRIMMED OFF AS MUCH AS WE COULD, BUT THE REST WAS SCARRED IN PLACE." THIS MDR WILL CAPTURE THE ALLEGED CATHETER ISSUE. THE PUMP FLIPPING ISSUE WILL BE CAPTURED IN MDR 3010079947-2023-00014.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16271715 ↗
• MalfunctionJan 18, 2023Insufficient Flow or Under Infusion; Migration; Insufficient Flow or Under Infusion; Migration

  AGENT CONTACTED TECHNICAL SOLUTIONS TO REPORT A VOLUME DISCREPANCY. AGENT STATED THAT A WEEK BEFORE, THE PATIENT CAME FOR A REFILL AND THE FULL 20 MLS WERE PULLED OUT OF THEIR PUMP. THE PATIENT HAD RECENTLY REPORTED AN INCREASE IN PAIN AND HAD NOT UNDERGONE ANY MRIS. A CAP STUDY WAS PERFORMED WHICH SHOWED THE CATHETER TO BE PATENT, BUT TIP HAD REPORTEDLY MIGRATED FROM T10 TO T1-T2. AGENT REPORTED THAT CSF WAS EASILY PULLED FROM THE CAP DURING THE CAP STUDY. AFTER THE DYE WAS INJECTED, A PRIMING BOLUS WAS NOT RUN IN ORDER TO VISUALIZE THE DYE BEING PRIMED THROUGH THE CATHETER. LATER COMMUNICATION WITH THE AGENT CONFIRMED THAT THE PHYSICIAN BELIEVED THAT THERE MIGHT BE AN ISSUE WITH THE PUMP AS THE CATHETER WAS "FINE". AGENT ALSO STATED THAT THE PATIENT'S VOLUME WAS CHECKED THE WEEK BEFORE, AND THE VOLUME WAS OBSERVED TO BE CORRECT. THE AGENT CONFIRMED THAT REVISION IS NOT SCHEDULED AT THIS TIME.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16194203 ↗
• InjuryJan 17, 2023Obstruction of Flow; Obstruction of Flow

  PATIENT TRACKING RECEIVED A TRACKING FORM REPORTING A CATHETER REVISION. THE REASON FOR REVISION WAS REPORTED TO BE A LOSS OF PAIN THERAPY. A CAP PROCEDURE WAS STATED TO HAVE BEEN PERFORMED IN WHICH THE CATHETER WAS UNABLE TO BE ASPIRATED. DEVICE WAS DISCARDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16183593 ↗
• InjuryJan 8, 2023Leak/Splash; Leak/Splash

  PATIENT TRACKING RECEIVED A FORM REPORTING A CATHETER REVISION DUE TO "CATHETER LEAKING." THE DEVICE WAS REPORTED TO BE DISCARDED. ADDITIONAL FOLLOW-UP WITH THE REPRESENTATIVE COVERING THE ISSUE CONFIRMED THAT THE LEAK WAS DIAGNOSED BY A CATHETER DYE STUDY. REPRESENTATIVE REPORTED THAT THE PATIENT EXPERIENCED A LACK OF EFFICACY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16119022 ↗
• InjuryDec 23, 2022Malposition of Device; Malposition of Device

  AGENT REPORTED THAT THE PATIENT HAD AN EXPLORATORY SURGERY PERFORMED ON THEIR PUMP POCKET FOLLOWING SWELLING AT THE PUMP SITE AFTER IMPLANT. THE AGENT STATED THAT THE EXACT DATE OF THE PROCEDURE WAS UNKNOWN, BUT THE PHYSICIAN WAS ABLE TO DIAGNOSE A CSF LEAK. PER AGENT, THIS WAS DUE TO THE PLACEMENT OF THE CATHETER AND DEVELOP PRETTY QUICKLY AFTER IMPLANT. A BLOOD PATCH WAS NOT PERFORMED, AND THE ISSUE HAS SINCE RESOLVED. THIS PATIENT IS THE SAME PATIENT REFERENCED IN MDR 3010079947-2022-00220.

  Patient problems: Cerebrospinal Fluid Leakage; Swelling/ Edema

  MAUDE report 16042456 ↗
• MalfunctionDec 16, 2022Fracture; Fracture

  AGENT CONTACTED TECHNICAL SOLUTIONS TO REPORT A BROKEN CATHETER THAT WAS OBSERVED IN A CATHETER DYE STUDY. AGENT STATED THAT THE DYE STUDY WAS DONE DUE TO A LACK OF PAIN RELIEF FELT BY THE PATIENT. THE DYE STUDY REPORTEDLY SHOWED THE CATHETER TO BE BROKEN NEAR THE SACRUM AND THE CATHETER TIP WAS "CLOSE TO WHERE THEY ENTERED THE INTRATHECAL SPACE." AGENT REPORTED THAT A CATHETER REVISION WILL BE DONE, BUT THIS PROCEDURE IS NOT SCHEDULED YET. AGENT STATED THAT THE PATIENT HAS NOT HAD ANY RECENT FALLS OR ACCIDENTS, AND THE PHYSICIAN IS UNSURE OF WHAT CAUSED THE BREAKAGE. AGENT WAS UNAWARE OF THE TYPE OF MEDICATION IN THE PATIENT'S PUMP OR THE DATE ON WHICH THE PATIENT SYMPTOMS STARTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15995632 ↗
• InjuryDec 16, 2022Insufficient Flow or Under Infusion; Material Twisted/Bent; Insufficient Flow or Under Infusion; Material Twisted/Bent

  CLINICAL SPECIALIST (CS) PROVIDED A PATIENT TRACKING IMPLANT FORM THROUGH EMAIL REPORTING A TOTAL SYSTEM REPLACEMENT. CS STATED THAT THE REPLACEMENT WAS DUE TO A LACK OF PAIN THERAPY AS WELL AS THE PUMP BEING ALMOST 10 YEARS OLD. A MYELOGRAM WAS PERFORMED AND THE CATHETER WAS UNABLE TO BE ASPIRATED. DURING THE SURGERY, IT WAS OBSERVED THAT THE MAJORITY OF THE CATHETER'S LENGTH WAS COILED BY THE SPINAL INCISION. CS STATED THAT THE PHYSICIAN SUSPECTS THAT THIS COILING IS THE REASON FOR THE DECREASE IN THERAPY. CS STATED THAT THEY ALSO BELIEVED THAT THE PATIENT HAD A FULL VOLUME DISCREPANCY AT THEIR LAST REFILL. CS REPORTED THAT THE PHYSICIAN ABANDONED THE CASE AFTER MULTIPLE ATTEMPTS TO RUN THE NEW CATHETER AND PLANS TO REFER THE PATIENT TO A NEUROSURGEON. THE NEW PUMP WAS PLACED IN THE EXISTING POCKET. THE OLD DEVICES WERE DISCARDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15995463 ↗
• InjuryDec 2, 2022Migration; Migration

  PATIENT TRACKING RECEIVED A TRACKING FORM IN THE MAIL REPORTING A CATHETER REVISION. PER FOLLOW-UP WITH THE REPRESENTATIVE, "CATH RETRACTED OUT OF INTRATHECAL SPACE AS VISUALIZED ON FLUOROSCOPY, COULD BE ANY NUMBER OF REASONS. PATIENT WAS NOT RECEIVING RELIEF TO AN ESCALATING DOSE. OLD CATH DISCARDED."

  Patient problems: Inadequate Pain Relief

  MAUDE report 15906435 ↗
• InjuryDec 2, 2022No Flow; No Flow

  PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL REPORTING A CATHETER REVISION. THE REVISED SEGMENT OF CATHETER WAS DISCARDED. PER FOLLOW-UP WITH THE REPRESENTATIVE COVERING THE ISSUE, "THE PATIENT WAS NOT GETTING ANY RELIEF FROM THE THERAPY. THE PHYSICIAN PERFORMED A CATHETER DYE STUDY AND COULD NOT GET ANY FLOW BACK FROM THE CATHETER. THIS WAS REPLICATED ONCE THE PUMP POCKET WAS OPENED IN SURGERY. WHY THIS HAPPENED IS UNKNOWN."

  Patient problems: Inadequate Pain Relief

  MAUDE report 15906337 ↗
• InjuryNov 29, 2022Fracture; Fracture

  PATIENT TRACKING RECEIVED A CATHETER REVISION TRACKING FORM REPORTING A CATHETER REVISION DUE TO IT BEING "BROKEN". ADDITIONAL COMMUNICATION WITH THE REPRESENTATIVE COVERING THE ISSUE CONFIRMED THAT THE CATHETER WAS SHEARED AT THE ENTRY POINT IN THE PATIENT'S SPINE. THIS CATHETER DAMAGE WAS DIAGNOSED WITH A CAP PROCEDURE WHICH OBSERVED THAT DYE WAS POOLED OUTSIDE OF THE SPINE. IT WAS REPORTED THAT THE PATIENT ALLEGED A LACK OF EFFICACY OF THEIR THERAPY. DURING THE REVISION SURGERY, THE CATHETER WAS TIED OFF AND NOT REMOVED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15880662 ↗
• InjuryNov 17, 2022Migration; Migration

  PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL REPORTING A CATHETER REVISION DUE TO CATHETER MIGRATION. THE CATHETER WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15814169 ↗
• InjuryNov 16, 2022Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Flow or Under Infusion; Obstruction of Flow

  PATIENT REPORTED A PUMP MALFUNCTION THAT HAD OCCURRED "ABOUT ONE MONTH AGO." PATIENT REPORTED THAT THEY BEGAN TO EXPERIENCE AN INCREASE IN PAIN AND WITHDRAWAL SYMPTOMS. THEY WENT TO THE EMERGENCY ROOM AND REPORTEDLY SUFFERED A "MYOCARDIAL INFARCTION". THE PATIENT REPORTS THEIR PUMP MANAGING PHYSICIAN DID A DYE STUDY AND A "SCAN THAT SHOWED THE VALVES" AS A RESULT OF THIS INCIDENT. THE PATIENT WAS UNABLE TO PROVIDE THE RESULT OF THE SCAN. THE PATIENT REPORTED THAT "THE DYE STUDY WAS INCONCLUSIVE" AND STATED THAT THE DOCTOR FELT IT WAS "MORE DIFFICULT THAN USUAL TO PUSH THE DYE THROUGH THE CATHETER". THE PATIENT'S PUMP WAS REPORTEDLY EMPTY AND OFF AT THE TIME OF THE REPORT. THE PATIENT REPORTS THAT THEY DID NOT EXPERIENCE ANY FALLS, ACCIDENTS, OR MRI'S PRIOR TO THIS INCIDENT. THE PATIENT REFERENCED A STATEMENT THAT "WAS MADE BY THE FDA THAT STATES CPAP MACHINES SHOULD NOT BE USED BY THOSE WITH IMPLANTED PUMPS." THE PATIENT INQUIRED IF THE CPAP MACHINE COULD HAVE AFFECTED THEIR PUMP TO WHICH TECHNICAL SUPPORT ADVISED THAT THE EVENTS APPEARED TO BE RELATED TO THE PATIENT'S CATHETER. PER FOLLOW-UP WITH THE PHYSICIAN'S OFFICE, THE RECEPTIONIST REPORTED THAT AN UNDERINFUSION VOLUME DISCRE

  Patient problems: Discomfort; Inadequate Pain Relief; Myocardial Infarction

  MAUDE report 15807258 ↗
• InjuryNov 1, 2022Migration; Migration

  PATIENT TRACKING RECEIVED A PATIENT TRACKING FORM THROUGH EMAIL REPORTING A CATHETER REVISION DUE TO CATHETER MIGRATION. AGENT STATED THAT THE PATIENT WASN'T GETTING PAIN RELIEF. AGENT STATED THAT THE PHYSICIAN AND THEIR TEAM PERFORMED A FEW IMAGING TESTS (X-RAY AND CT SCANS) PRIOR TO SCHEDULING SURGERY AND DETERMINED THAT THE PATIENT'S CATHETER HAD MIGRATED. THE DEVICE WAS DISCARDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15710698 ↗
• InjuryNov 1, 2022Insufficient Flow or Under Infusion; Migration; Insufficient Flow or Under Infusion; Migration

  PHYSICIAN CONTACTED TECHNICAL SOLUTIONS TO REPORT AN UNDERINFUSION VOLUME DISCREPANCY. IT WAS REPORTED THAT THE PATIENT HAD BEEN COMPLAINING ABOUT A LACK OF PAIN RELIEF SINCE THE TIME OF THEIR LAST REFILL. WHEN THE VOLUME DISCREPANCY WAS OBSERVED, THE FULL REFILL VOLUME WAS PULLED OUT OF THE PUMP. A CATHETER REVISION WAS LATER PERFORMED WHICH IDENTIFIED THAT THE PATIENT'S CATHETER HAD MIGRATED. A NEW CATHETER WAS PLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15710697 ↗
• InjuryOct 31, 2022Migration; Migration

  PATIENT TRACKING RECEIVED A TRACKING FORM VIA EMAIL REPORTING A CATHETER REVISION DUE TO "MIGRATION OUT OF IT SPACE." AGENT STATED THAT THE CATHETER MIGRATION WAS IDENTIFIED BY A CSF LEAK AND SUBSEQUENT PATIENT HEADACHE. THE PHYSICIAN DID NOT KNOW WHY THE CATHETER MIGRATED. THE CATHETER WAS DISCARDED.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 15702859 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P080012. One submission often covers many models, so check the product and lot details in each record.

• Z-1996-2021 · May 26, 2021 · Terminated
  Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System: MODEL/CATALOG #(s): Catalog No. US Mode
• Z-1120-2020 · Dec 24, 2019 · Open, Classified
  Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082
• Z-1121-2020 · Dec 24, 2019 · Open, Classified
  Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
• Z-1123-2020 · Dec 24, 2019 · Open, Classified
  US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082
• Z-1122-2020 · Dec 24, 2019 · Open, Classified
  Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
• Z-1124-2020 · Dec 24, 2019 · Open, Classified
  Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)
• Z-1125-2020 · Dec 24, 2019 · Open, Classified
  Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)
• Z-1713-2019 · Mar 21, 2019 · Terminated
  Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
• Z-1715-2019 · Mar 21, 2019 · Terminated
  Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.
• Z-1712-2019 · Mar 21, 2019 · Terminated
  Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
• Z-1716-2019 · Mar 21, 2019 · Terminated
  Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
• Z-1714-2019 · Mar 21, 2019 · Terminated
  Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
• Z-2740-2017 · May 22, 2017 · Terminated
  PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction i