NA 387360Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169157385), received between Dec 12, 2016 and Dec 19, 2023 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2023Impedance Problem; Impedance Problem

  INFORMATION WAS RECEIVED FROM A PATIENT VIA DISTRIBUTOR WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDI CATIONS FOR USE. IT WAS REPORTED THAT THE ELECTRIC RESISTANCE OF LEAD WAS ABNORMAL. ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS DIAGNOSTICS/TROUBLESHOOTING PERFORMED ARE NOT KNOWN. PATIENT ALIVE WITH NO INJURIES. THE ISSUE IS LISTED AS RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED. ISSUE OF LEAD ABNORMAL ELECTRICAL RESISTANCE DISCOVERED PRE-IMPLANT, OUT OF BOX ISSUE WITH NO PATIENT CONTACT. THE LEAD IS SET TO BE RETURNED, NO TRACKING INFORMATION HAS YET BEEN UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18358204 ↗
• MalfunctionMar 27, 2023Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING A PATIENT WHO WAS BEING IMPLANTED WITH A TRIAL LEAD. IT WAS REPORTED THAT INTRAOPERATIVE THE DOCTOR COULD NOT PUNCTURE DURING THE PUNCTURE. AFTER PULLING OUT, THE PUNCTURE NEEDLE STUCK ON THE LEAD. WHEN THE PUNCTURE NEEDLE WAS SEPARATED FROM THE LEAD, THE LEAD WAS FOUND THAT THERE WAS A SMALL GAP AT THE LOWER END OF THE "LAST ELECTRIC SHOCK", AND THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING WITH A NEW LEAD 3873, AND THE PATIENT IS CURRENTLY HOSPITALIZED FOR OBSERVATION. EFFECTIVE MEASURES HAVE BEEN TAKEN INCLUDING THAT THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING IT WITH A NEW LEAD. THE DEVICE WILL BE RETURNED. THERE WAS NO PATIENT DEATH OR INDICATION OF INJURY. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT BEING CURRENTLY HOSPITALIZED FOR OBSERVATION WAS THE NORMAL, EXPECTED POST-OPERATIVE HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16619831 ↗
• MalfunctionSep 20, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT AFTER UNPACKING DURING SURGERY, IT WAS FOUND THAT THERE WAS AN ABNORMAL RED MARK ON THE CORNER OF THE INNER BOX WRAPPING PAPER OF THE LEAD. THE HOSPITAL SAID THAT IT COULD NOT BE USED FOR THE PATIENT SO A NEW LEAD WAS OPENED AND USED. THE SURGERY WAS COMPLETED WITH ANOTHER LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15455195 ↗
• MalfunctionMay 16, 2022High impedance; High impedance

  THE MANUFACTURING REPRESENTATIVE REPORTED THAT AFTER AN INTRAOPERATIVE TEST, IT WAS FOUND THAT THE LEAD COULD NOT MEASURE RESISTANCE. A NEW LEAD WAS REPLACE DON THE SAME DAY TO COMPLETE THE OPERATION. THE PATIENT WAS CURRENTLY UNDER OBSERVATION IN THE HOSPITAL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEAD RESISTANCE WAS TOO HIGH. THEY WERE UNABLE TO MEASURE THE IMPEDANCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14408956 ↗
• MalfunctionJun 1, 2021Impedance Problem; Impedance Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (FOREIGN, DISTRIBUTOR) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE RESISTANCE OF THE LEAD COULD NOT BE DETECTED DURING THE SURGERY AND COULD NOT BE USED NORMALLY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE LEAD WITH A NEW ONE. THE PATIENT WAS IN THE HOSPITAL UNDER OBSERVATION. THE PATIENT WAS IN GOOD CONDITION WITH NORMAL TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11916501 ↗
• MalfunctionJun 22, 2020Break; Difficult to Insert; Break; Difficult to Insert

  THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THROUGH A MANUFACTURER REPRESENTATIVE, THAT BECAUSE THE ¿PATIENT¿S SPINAL CANAL ENVIRONMENT WAS NOT GOOD,¿ THE DOCTOR REMOVED THE CURVED STYLET FROM THE LEAD BEFORE IMPLANTING THE LEAD AND TRIED TO INSERT THE STRAIGHT STYLET. THE HCP FOUND THE STRAIGHT STYLET ¿COULDN¿T BE INSERTED INTO THE LEAD.¿ THE HCP TRIED TO RE-INSERT THE STYLET MANY TIMES BUT FAILED; THEY ¿THOUGHT THAT THE INSIDE OF THE LEAD WAS NOT SMOOTH.¿ THE LEAD WAS REPLACED WITH ANOTHER LEAD KIT AND THE ISSUE WAS RESOLVED. THE LEAD WAS NEVER IMPLANTED. THERE WERE NO SURGICAL INTERVENTIONS PERFORMED AND IT WAS UNKNOWN WHETHER ANY WERE PLANNED. NO COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10181125 ↗
• MalfunctionMar 3, 2020Difficult to Insert; Human-Device Interface Problem; Difficult to Insert; Human-Device Interface Problem

  THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THROUGH A MANUFACTURER REPRESENTATIVE THAT THE LEAD WAS ALWAYS BENT IN THE EPIDURAL SPACE DURING THE IMPLANT SURGERY. WHEN THE SURGEON CONSIDERED REPLACING THE GUIDE WIRE, HE FOUND THAT ONLY TWO-THIRDS OF THE GUIDE WIRE COULD BE PUT IN AND THE TIP OF THE LEAD WAS NOT BENT. REPEATED ATTEMPTS FAILED TO INSERT THE GUIDE WIRE COMPLETELY INTO THE LEAD. THE LEAD WAS REPLACED AS A RESULT OF THE EVENT AND THE ISSUE WAS RESOLVED. IT WAS NOTED THERE WERE NO PHYSICAL ISSUES OBSERVED WITH THE LEAD OR GUIDEWIRE AND THE CAUSE OF THE INABILITY TO FULLY INSERT THE GUIDEWIRE INTO THE LEAD WAS NOT DETERMINED. THERE WERE NO EXTERNAL FACTORS REPORTED THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9781023 ↗
• MalfunctionDec 5, 2019Break; Break

  IT WAS REPORTED THE LEAD WAS DAMAGED DURING THE SURGERY AND THE SURGERY COULD NOT BE CONTINUED. THE DAMAGE WAS NOTED AS VISIBLE TO THE NAKED EYE. THE LEAD WAS REPLACED AS A RESULT OF THE EVENT, THE SURGERY WAS COMPLETED, AND THE ISSUE WAS RESOLVED. THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF REPORT. NO COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9415570 ↗
• InjurySep 11, 2019Break; Device Damaged Prior to Receipt by User; Positioning Problem; Break; Device Damaged Prior to Receipt by User; Positioning Problem

  IT WAS REPORTED THE LEAD HAD BURRS AND THAT THE LEAD BURRS WERE IDENTIFIED AFTER THE LEAD WAS IN THE PATIENT. IT WAS STATED THAT AFTER THE PUNCTURE WAS COMPLETED, IT WAS FOUND THE LEAD POSITION COULD NOT BE ADJUSTED DURING LEAD DELIVERY. THE LEAD WAS REPLACED AFTER THE PROBLEM WAS FOUND AND THE ISSUE WAS RESOLVED. IT WAS NOTED THAT A SURGICAL INTERVENTION WAS REQUIRED TO REPLACE THE LEAD AND COMPLETE THE SURGERY. THE LEAD ISSUE WAS CONSIDERED AN OUT OF BOX ISSUE, AS IT THE POSITION COULD NOT BE ADJUSTED DURING THE FIRST TIME PLACEMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8995049 ↗
• MalfunctionDec 12, 2016Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE TRIAL LEAD WAS UNABLE TO ADVANCE THROUGH THE TOUHY NEEDLE. STYLETS WERE SWAPPED TO TROUBLESHOOT BUT WERE UNSUCCESSFUL. NEEDLE ANGLE WAS RECHECKED AND LOSS OF RESISTANCE RECHECKED. A NEW TRIAL LEAD WAS OPENED AND ADVANCED WITHOUT TROUBLE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO SURGICAL INTERVENTION OCCURRED OR WAS PLANNED. THE PATIENT¿S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE LEAD HAD BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6166151 ↗