Nalu Medical, Inc. 71005-US (UDI 00812537033600)Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00812537033600), received between Aug 28, 2020 and Sep 22, 2026 — classified as 39 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 3, 2024Class IIOpen, Classified

   Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which causes the device to be non-functional so it will no longer inhibit the transmission of pain signals to the brain.

   Z-2257-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859840 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK, HIP, AND PELVIC PAIN AFTER PARTICIPATING IN A SUCCESSFUL TRIAL PHASE. DURING A FOLLOW-UP ON (B)(6) 2024 THE PATIENT REPORTED THAT PAIN LEVELS HAD DECREASED FROM 7/10 DOWN TO 3/10. PATIENT LATER REPORTED ONSET OF NEW PAIN SYMPTOMS AT THE LOCATION OF THE IMPLANTABLE PULSE GENERATOR (IPG) AND STIMULATION OUTSIDE OF THE DESIRED LOCATION. THE IPG WAS FOUND TO HAVE MIGRATED OVER TOP OF THE SPINE, CAUSING THE DISCOMFORT. A SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2024 TO CREATE A NEW POCKET TO REPOSITION THE EXISTING IPG OFF THE SPINAL COLUMN. DURING THE PROCEDURE, THE IMPLANTED LEADS WERE DAMAGED AND REQUIRED REPLACEMENT. THE NEW LEADS WERE POSITIONED BACK AT THE DESIRED NERVE TARGET TO RESTORE THERAPY AND THE PATIENT REPORTED GOOD PAIN RELIEF FROM THE SYSTEM. SEE MDR 3015425075-2024-00282. AFTER THE INITIAL IMPLANT AND THROUGHOUT THE COURSE OF TREATMENT, DESPITE RECEIVING PAIN RELIEF FROM THE NALU SYSTEM, THE PATIENT NOTED A FLAREUP OF A PRE-EXISTING AUTOIMMUNE DISORDER. THE PATIENT WORKED WITH THEIR PHYSICIANS TO CONTROL THE SYMPTOMS; HOWEVER, IT WAS ULTIMATELY SUGGESTED THAT HAVIN

  Patient problems: Unspecified Immune System Problem

  MAUDE report 21730944 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2023. ON (B)(6) 2024 THE FIRM WAS NOTIFIED THAT THE SYSTEM WAS BEING EXPLANTED THAT DAY. PER THE PHYSICIAN, THE PATIENT'S BASELINE PAIN LEVELS HAD DECREASED AND THE NALU SYSTEM WAS NOT BEING USED CONSISTENTLY. THE EXPLANT WAS DONE PER THE PATIENT REQUEST DUE TO NOT USING THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578961 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2021 TO TREAT LOWER BACK PAIN. THE NALU SYSTEM WAS IN USE FOR MORE THAN 3 YEARS WITH NO ISSUES. SYSTEM INITIALLY PROVIDED GOOD PAIN RELIEF, HOWEVER THE PATIENT'S EXISTING CONDITIONS PROGRESSED AND THE THERAPY PROVIDED BY THE NALU SYSTEM LESSENED. WORKING WITH A NEUROSURGEON, THE PATIENT CHOSE TO MOVE FORWARD WITH SPINAL FUSION TO ADDRESS THE EXISTING CONDITIONS. ON (B)(6) 2024 THE NALU SYSTEM WAS SURGICALLY EXPLANTED IN PREPARATION FOR THE PLANNED SPINAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195926 ↗
• InjuryAug 15, 2024Circuit Failure; Circuit Failure

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2021 TO TREAT LOWER BACK PAIN. DURING A REPROGRAMING IT WAS NOTED THAT BOTH IMPLANTED LEADS WERE RETURNING IMPEDANCE ERRORS INDICATING AN OPEN CIRCUIT. IMPEDANCE ERRORS WERE FIRST NOTED WITH 2 ELECTRODES ONLY ON (B)(6) 2023, HOWEVER THE SYSTEM WAS STILL PROVIDING ADEQUATE PAIN RELIEF. ON (B)(6) 2024 6 ELECTRODES WERE RETURNING THE ERROR CODE AND THE PATIENT WAS NO LONGER RECEIVING ADEQUATE PAIN RELIEF. A SURGICAL INTERVENTION WAS PERFORMED ON (B)(6) 2024 TO REPLACE THE MALFUNCTIONING SYSTEM,

  Patient problems: Inadequate Pain Relief

  MAUDE report 19988873 ↗
• InjuryJul 25, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT BACK PAIN. DURING A FOLLOW-UP IN APRIL 2024 THE PATIENT REPORTED THAT PAIN LEVELS HAD DECREASED FROM 7/10 DOWN TO 3/10. PATIENT LATER REPORTED ONSET OF NEW PAIN SYMPTOMS AT THE LOCATION OF THE IMPLANTABLE PULSE GENERATOR (IPG) AND STIMULATION OUTSIDE OF THE DESIRED LOCATION. DURING A PHYSICAL VISIT THE IMPLANT SITE WAS VISUALLY ASSESSED AND FOUND THAT THE IPG HAD MIGRATED TO A LOCATION THAT WAS OVER THE SPINAL COLUMN. IMAGING WAS TAKEN AND CONFIRMED THAT THE IPG WAS NO LONGER IN ITS ORIGINAL LOCATION AND THE IMPLANTED LEADS HAD ALSO MIGRATED AWAY FROM THE INTENDED TARGET, CAUSING THE UNWANTED STIMULATION. FURTHER ASSESSMENT FOUND THAT THE POCKET CREATED DURING THE IMPLANT PROCEDURE WAS TOO LARGE AND DID NOT PROVIDE THE DESIRED STABILITY FOR THE IPG, ALLOWING IT TO MIGRATE AND CAUSE PAIN. A SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2024 TO CREATE A NEW POCKET AND REPOSITION THE EXISTING IPG OFF THE SPINAL COLUMN. DURING THE PROCEDURE, THE IMPLANTED LEADS WERE DAMAGED AND REQUIRED REPLACEMENT. THE NEW LEADS WERE POSITIONED BACK AT THE DESIRED NERVE TARGET TO RESTORE THERAPY FOR THE PATIENT.

  Patient problems: Implant Pain

  MAUDE report 19826594 ↗
• InjuryMay 24, 2024Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2021. IN (B)(6) 2024 THE PATIENT REPORTED SOME ISSUES WITH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS, ULTIMATELY LEADING TO INADEQUATE PAIN RELIEF FROM THE SYSTEM. INVESTIGATION AND TROUBLESHOOTING FOUND THAT THE PATIENT HAD SUSTAINED SIGNIFICANT WEIGHT LOSS AFTER THE NALU SYSTEM HAD BEEN IMPLANTED. THE COMMUNICATION ISSUES WERE DETERMINED TO BE DIRECTLY RELATED TO THE PATIENT WEIGHT LOSS. WEIGHT LOSS REDUCES THE STABILITY OF THE IPG DUE TO LOSS OF TISSUE AND INCREASE IN LOOSE SKIN. PATIENT WAS SCHEDULED FOR SURGICAL REVISION IN ORDER TO MOVE THE IPG TO A MORE STABLE LOCATION OR POSITION AS RELATED TO THE PATIENT'S CURRENT ANATOMICAL MAKEUP. DURING THE PROCEDURE, ON (B)(6) 2024, THE EXISTING IPG WAS DAMAGED AND REQUIRED REPLACEMENT. ADDITIONALLY, THE EXISTING LEADS WERE INADVERTENTLY PULLED OUT OF PLACE DURING THE PROCEDURE AND WERE ALSO REPLACED WITH A NEW SET OF LEADS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19397786 ↗
• InjuryMay 10, 2024Impedance Problem; Impedance Problem

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2021. DURING A PRE-MRI SYSTEM CHECK IN (B)(6) 2024, IMPEDANCE ISSUES WERE DISCOVERED ON SEVERAL OF THE LEAD CONTACTS. PATIENT REPORTED CONTINUING TO RECEIVED THERAPY AND PAIN RELIEF FROM THE SYSTEM AND REPORTED NO FALLS OR OTHER OBVIOUS EXTERNAL FACTORS THAT MAY HAVE DAMAGED THE IMPLANTED COMPONENTS. NO IMAGING WAS PERFORMED TO VIEW THE SYSTEM. IN (B)(6) 2024 THE PATIENT WAS ADMITTED TO AN ACUTE FACILITY WITH NEUROLOGICAL DEFICITS AND WAS RECOMMENDED TO HAVE AN MRI TO ASSIST IN THE DIAGNOSIS OF SYMPTOMS. SYSTEM WAS AGAIN CHECKED AND IMPEDANCE ISSUES PERSISTED ON 2 OF THE CONTACTS, MAKING MRI NOT POSSIBLE WITH THE SYSTEM AS-IS. A FULL SYSTEM EXPLANT TOOK PLACE ON (B)(6) 2024 IN ORDER TO ALLOW THE MRI TESTING TO TAKE PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19294482 ↗
• InjuryApr 22, 2024Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2021 TO TREAT PELVIC PAIN. ON (B)(6) 2024 A FULL SYSTEM EXPLANT TOOK PLACE IN ORDER FOR THE PATIENT TO PROCEED WITH ABDOMINAL MRI FOR RECTAL CANCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19150216 ↗
• InjuryApr 22, 2024Impedance Problem; Impedance Problem

  ON (B)(6) 2024 THE PATIENT MET WITH A NALU REPRESENTATIVE FOR IMPEDANCE CHECK DUE TO INADEQUATE PAIN RELIEF FROM THE NALU SYSTEM. IMPEDANCE CHECK RETURNED READINGS INDICATING AN OPEN CIRCUIT OR POSSIBLE SHORT IN THE SYSTEM. IMAGING FOUND THE IMPLANTABLE PULSE GENERATOR (IPG) HAD MIGRATED WITHIN THE POCKET BUT SHOWED NO OTHER OBVIOUS DAMAGE TO THE SYSTEM COMPONENTS. SURGICAL REVISION WAS PERFORMED ON (B)(6) 2024 TO REPLACE THE IPG. EXISTING LEADS REMAINED IMPLANTED AND IN USE. EXISTING LEADS WERE TESTED INTRA-OP WITH A KNOWN GOOD DEVICE TO CONFIRM NO ISSUES WITH THE LEADS AND VERIFY ONLY THE IPG HAD BEEN DAMAGED. ADDITIONAL INTRA-OP TESTING CONFIRMED THE REPLACEMENT IPG RETURNED GOOD IMPEDANCE READINGS AND WAS FUNCTIONING AS EXPECTED PRIOR TO CLOSING THE CASE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19150215 ↗
• InjuryApr 10, 2024Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATION SYSTEM ON (B)(6) 2022. ON 11MAR2024, THE FIRM BECAME AWARE THAT THE SYSTEM HAD BEEN EXPLANTED ON (B)(6) 2024 DUE TO PATIENT NEEDING AN MRI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085392 ↗
• InjuryApr 5, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2022 TO TREAT LOWER BACK PAIN. IN (B)(6) 2024 THE PATIENT NOTED SOME LOSS OF PAIN RELIEF FROM THE SYSTEM. IMAGING WAS PERFORMED AND FOUND LEAD MIGRATION. SURGICAL INTERVENTION WAS SCHEDULED TO PLACE THE LEAD BACK TO THE ORIGINAL IMPLANT LOCATION. DURING THE PROCEDURE ON (B)(6) 2024 THE EXISTING IMPLANTED COMPONENTS WERE DAMAGED WHILE ATTEMPTING TO REPOSITION, THUS NECESSITATING REPLACEMENT OF BOTH THE LEADS AND THE IMPLANTABLE PULSE GENERATOR.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19056418 ↗
• InjuryMar 23, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2022. IN (B)(6) 2024 THE PATIENT NOTIFIED A NALU REPRESENTATIVE THAT THERE WAS A LOSS OF STIMULATION A "COUPLE OF MONTHS" PRIOR. XRAY IMAGING FOUND THAT THE IMPLANTED LEADS HAD MIGRATED AND WERE NO LONGER TARGETING THE DESIRED LOCATION. A SURGICAL REVISION WAS PERFORMED ON (B)(6) 2024 TO REPLACE THE MIGRATED LEADS. DURING THE PROCEDURE, HANDLING OF THE IMPLANTABLE PULSE GENERATOR (IPG) CAUSED DAMAGE AND CAUSED THE IPG TO ALSO REQUIRE REPLACEMENT. ORIGINAL IPG LOCATION WAS ON THE RIGHT LOWER BACK. A NEW POCKET WAS CREATED FOR THE NEW IPG ON THE LEFT LOWER BACK, SLIGHTLY LEFT OF THE MIDLINE INCISION. NEW LEADS WERE PLACED IN THE T8-T9 VICINITY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18966294 ↗
• InjuryJan 6, 2024Fracture; Migration; Fracture; Migration

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2022. PATIENT HAD REPORTED RECEIVING GOOD THERAPY FROM THE SYSTEM AFTER IMPLANT. IN (B)(6) 2023 THE PATIENT REPORTED HAVING SUSTAINED MULTIPLE FALLS AND SUBSEQUENT LOSS OF PAIN RELIEF FROM THE NALU SYSTEM. IMAGING AND IMPEDANCE CHECKS DETERMINED THAT ONE OF THE IMPLANTED LEADS HAD FRACTURED AND THE OTHER IMPLANTED LEAD HAD MIGRATED AWAY FROM THE TARGET AREA FOR PAIN RELIEF. ON (B)(6) 2023 A SURGICAL REVISION WAS PERFORMED IN WHICH ALL OF THE IMPLANTED COMPONENTS WERE REPLACED AND NEW COMPONENTS WERE IMPLANTED AT THE TARGET LOCATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18461075 ↗
• InjuryNov 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR ON (B)(6) 2022 TO TREAT LOWER BACK PAIN. AFTER BEING IMPLANTED THE PATIENT IS REPORTED TO HAVE LOST A SIGNIFICANT AMOUNT OF WEIGHT AND SUBSEQUENTLY REPORTS ISSUES WITH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. A REVISION PROCEDURE TOOK PLACE ON (B)(6) 2023. INITIAL PLAN WAS TO REPOSITION THE IPG WITHIN THE EXISTING POCKET TO MAKE IT MORE STABLE FOR THE PATIENT'S CURRENT PHYSIQUE. WHILE CUTTING THROUGH THE SCAR TISSUE TO ACCESS THE IPG, THE POCKET BECAME ENLARGED AND WAS NO LONGER USABLE. THE EXISTING POCKET WAS LOCATED ON THE RIGHT LOWER BACK, A NEW POCKET WAS CREATED ON THE LEFT LOWER BACK AREA. WHILE REMOVING THE IPG TO MOVE IT TO THE NEW POCKET, THE DEVICE WAS DAMAGED AND BECAME NO LONGER USABLE. A NEW IPG AND LEADS WERE PLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18116826 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2022 TO TREAT LOW BACK PAIN. AFTER HAVING THE IMPLANT FOR MORE THAN ONE YEAR THE PATIENT REPORTED THAT THE PAIN BEING FELT PREVIOUSLY HAS SUBSIDED AND PATIENT FEELS THEY NO LONGER NEED THE NALU SYSTEM. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2023 PER THE PATIENT REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18010525 ↗
• InjurySep 14, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR (SCS) SYSTEM ON (B)(6) 2022 TO REPLACE AN EXISTING COMPETITOR SYSTEM TREATING LOWER BACK PAIN. PATIENT WAS ABLE TO ACHIEVE SOME PAIN RELIEF WITH THE SYSTEM. ON (B)(6) 2023 THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR (PNS) TRIAL SYSTEM TARGETING THE CLUNEAL NERVE AND WAS ABLE TO ACHIEVE BETTER PAIN RELIEF FOR THE SAME LOWER BACK PAIN. PER PATIENT REQUEST, ON (B)(6) 2023 THE EXISTING SCS SYSTEM WAS EXPLANTED AND A PERMANENT PNS SYSTEM WAS IMPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17743564 ↗
• InjuryAug 18, 2023Malposition of Device; Malposition of Device

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR ON (B)(6) 2022. PATIENT SUBSEQUENTLY NOTED THAT THERE WERE ISSUES WITH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS WHICH WAS DETERMINED TO BE CAUSED BY THE DEPTH OF THE IPG. A SURGICAL REVISION WAS PERFORMED ON (B)(6) 2023 TO MOVE THE IPG TO A MORE SUPERFICIAL LOCATION (SEE MDR 3015425075-2023-00014). INVESTIGATION WAS CONDUCTED AT THE TIME OF THE REVISION AND WAS UNABLE TO FULLY DETERMINE IF THE DEVICE HAD MIGRATED OR WAS INCORRECTLY POSITIONED AT THE TIME OF IMPLANT. AFTER THE REVISION, THE PATIENT AGAIN REPORTED ONGOING COMMUNICATION ISSUES BETWEEN THE IPG AND THE THERAPY DISCS, CAUSING SPORADIC PAIN RELIEF THERAPY. ON (B)(6) 2023 A SECOND REVISION WAS PERFORMED TO MOVE THE IPG TO A POSITION THAT IS MORE CONDUCIVE TO CONNECTIVITY BETWEEN THE DEVICES.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17580015 ↗
• InjuryAug 2, 2023Migration; Migration

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2021 AND SUBSEQUENTLY REPORTED A LOSS OF PAIN RELIEF THERAPY. XRAY IMAGING CONFIRMED MIGRATION OF THE IMPLANTED LEADS. SURGICAL REVISION WAS PERFORMED ON (B)(6)2022 TO PLACE NEW LEADS INTO A MORE OPTIMAL LOCATION TO PROVIDE PAIN RELIEF.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17446514 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2021 TO TREAT LOWER BACK PAIN. AFTER IMPLANT THE PATIENT REPORTED DEVELOPMENT OF PAIN IN A NEW LOCATION. ON (B)(6) 2022 A TRIAL COURSE WAS INITIATED FOR THE ADDITIONAL PAIN LOCATION. SURGICAL REVISION WAS PERFORMED ON (B)(6) 2022 TO REMOVE ONE OF THE IMPLANTED LEADS AND PLACE A NEW LEAD TO BETTER TARGET THE ADDITIONAL PAIN LOCATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17446375 ↗
• InjuryAug 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2022. ON (B)(6) 2022 A SURGICAL REVISION WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 17443696 ↗
• InjuryAug 1, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2021. AFTER IMPLANTATION THE PATIENT REPORTED PAIN OR DISCOMFORT AT THE MIDLINE INCISION. INVESTIGATION BY THE PHYSICIAN DETERMINED THAT THE IMPLANTED ANCHORS WERE TOO SUPERFICIAL. SURGICAL REVISION WAS PERFORMED ON (B)(6) 2022 TO MOVE THE ANCHORS TO A DEEPER LOCATION. PATIENT REPORTS RECEIVING THERAPY AND NO FURTHER DISCOMFORT.

  Patient problems: Discomfort

  MAUDE report 17435179 ↗
• InjuryAug 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT SUCCESSFULLY COMPLETED A TRIAL OF THE NALU SPINAL CORD STIMULATOR SYSTEM IN (B)(6) 2022 AND WAS IMPLANTED WITH A PERMANENT SYSTEM ON (B)(6) 2022. AFTER IMPLANT THE PATIENT REPORTED THAT THE SYSTEM WAS NOT WORKING AND DECLINED TO PERFORM ANY TROUBLESHOOTING WITH A NALU REPRESENTATIVE. THE SYSTEM WAS EXPLANTED ON (B)(6) 2022.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17435165 ↗
• InjuryJul 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2021. AFTER ACTIVATING THE NALU SYSTEM THE PATIENT SUSTAINED WEIGHT GAIN, LEADING TO COMMUNICATION ISSUES BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. THE PATIENT REPORTED INTERMITTENT PAIN RELIEF DUE TO THE COMMUNICATION ISSUES. ON (B)(6) 2022 A SURGICAL REVISION WAS PERFORMED TO MOVE THE IPG TO A MORE OPTIMAL LOCATION FOR THE PATIENT TO MAINTAIN CONSISTENT CONNECTIVITY AND PAIN RELIEF.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17421641 ↗
• InjuryJul 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR ON (B)(6) 2021. PATIENT REPORTED SYSTEM BEGAN TO FUNCTION SPORADICALLY AND NOT PROVIDE CONSISTENT THERAPY. PATIENT CHOSE TO FOLLOW UP WITH A DIFFERENT DOCTOR. XRAY IMAGING WAS PERFORMED AND DID NOT INDICATE ANY OBVIOUS ISSUES WITH THE IMPLANTED COMPONENTS. NEW DOCTOR RECOMMENDED TO EXPLANT THE ENTIRE SYSTEM AND START FRESH WITH ALL NEW INTERNAL AND EXTERNAL COMPONENTS. SYSTEM REPLACEMENT WAS PERFORMED ON (B)(6) 2023 AND REPLACED THE IMPLANTABLE PULSE GENERATOR, LEADS, AND EXTERNAL THERAPY DISCS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17414820 ↗