InterStim SureScanRecalls & reported problems across all models

We found 7 models of InterStim SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 110 adverse event reports in the FDA's MAUDE database, received between Sep 1, 2020 and Jun 25, 2026 — classified as 44 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (38 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported InterStim SureScan problems

InterStim SureScan models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• InterStim™ SureScan™ 978B128

  Stimulator, electrical, implantable, for incontinence
  58 reports
• InterStim™ SureScan™ 978B128

  Stimulator, electrical, implantable, for incontinence
  32 reports
• InterStim™ SureScan™ 978A128

  Stimulator, electrical, implantable, for incontinence
  9 reports
• InterStim™ SureScan™ 978B133

  Stimulator, electrical, implantable, for incontinence
  5 reports
• InterStim™ SureScan™ 978B128

  Stimulator, electrical, implantable, for incontinence
  4 reports
• InterStim™ SureScan™ 978A141

  Stimulator, electrical, implantable, for incontinence
  1 report
• InterStim™ SureScan™ 978A128

  Stimulator, electrical, implantable, for incontinence
  1 report

Recent InterStim SureScan adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Break; Difficult to Remove; Material Separation; Material Twisted/Bent; Positioning Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE REASON FOR CALL WAS CALLER REPORTED THE PHYSICIAN PUT THE LEAD INTRODUCER IN WITH THE SHEATH AND THE FORAMEN WAS VERY "TIGHT AND CRUNCHY" AND THE TIP OF THE PLASTIC ON THE INTRODUCER (WITH THE RADIOPAQUE IDENTIFIER) BROKE OFF. CALLER INQUIRED ABOUT MATERIAL SPECIFICATIONS AND BIOCOMPATIBILITY OF THE INTRODUCER GIVEN THAT THE TIP WAS DOWN UNDER THE SACRUM WHERE THE PHYSICIAN WAS UNABLE TO RETRIEVE IT. CALLER STATED THAT PARTIAL INTRODUCER WAS DISCARDED IN THE OR WHEN THEY HAD TO GET A NEW KIT. AGENT DOCUMENTED REPORTED INFORMATION AND REACHED OUT TO ENGINEERING FOR MORE INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25619831 ↗
• MalfunctionMay 8, 2026Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION. IT WAS REPORTED THAT THE LEAD WAS DEFECTIVE AS IT'S APPEARANCE WAS NOT NORMAL. THE WIRE BETWEEN THE ELECTRODES APPEARED TO BE EXPOSED. THE CAUSE WAS UNKNOWN. THEY OPENED A NEW LEAD COMPARED THE TWO AND THERE WAS A DEFINITIVE DIFFERENCE AT THE ELECTRODE SITE. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125599 ↗
• MalfunctionMay 5, 2026Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-OBSTRUCTIVE URINARY RETENTION. IT WAS REPORTED THAT THE INTRODUCER SHEATH FROM THE LEAD KIT BROKE. THE PLASTIC PIECE AT THE TOP BROKE OFF FROM THE INNER METAL PIECE. THE CAUSE WAS UNKNOWN. A REVISION KIT WAS OPENED TO OBTAIN A NEW INTRODUCER SHEATH WHICH RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086558 ↗
• MalfunctionApr 21, 2026Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION; URGE INCONTINENCE IT WAS REPORTED THAT " PATIENT (PT) SAID A LITTLE WHILE BACK THEY HAD TO HAVE AN MRI DONE AND HEY NOTICED THE LEAD TO THEIR STIMULATOR HAD TO COME AND ATTACHED AND THEY HAD MAJOR ISSUES WITH THAT NOT BEING IN WORKING ORDER. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PT SAID THEY HAD SEEN A DOCTOR AT FIRST UROLOGY, DR WHO SENT THEM TO A DOCTOR TO PUT IT IN. CALL DISCONNECTED, CALLED PT BACK 2 CALL RECORDINGS, CALLED PATIENT BACK, NO ANSWER, LEFT MESSAGE TO CALL PATS IF THEY NEEDED FURTHER ASSISTANCE.

  Patient problems: Insufficient Information

  MAUDE report 24940846 ↗
• MalfunctionJan 19, 2026Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION (INCONTINENCE, URGENCY, AND/OR FREQUENCY). IT WAS REPORTED THAT THE END OF THE LEAD CONTAINED A BENT TIP STYLET THAT WAS NOT CURVED AS IT TYPICALLY IS. THE PHYSICIAN WAS UNABLE TO GET THE LEAD TO CURVE PROPERLY ONCE IT WAS PLACED THROUGH THE LEAD INTRODUCER. TROUBLESHOOTING WAS PERFORMED, AND AFTER SEVERAL ATTEMPTS, THE LEAD WAS COMPLETELY REMOVED FROM THE INTRODUCER, AT WHICH POINT THE PHYSICIAN NOTICED THAT THE LEAD WAS NOT CURVED AS IT TYPICALLY IS. A NEW LEAD KIT WAS OPENED AND USED, WHICH WAS FROM THE SAME LOT NUMBER AND WAS VISIBLY CURVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24112211 ↗
• InjuryDec 1, 2025Failure to Deliver Energy; High impedance; Failure to Deliver Energy; High impedance

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE PATIENT'S DOCTOR PROVIDED A DETAILED SUMMARY. IN THE DETAILED SUMMARY, IT WAS NOTED THAT "PREOPERATIVE ANTIBIOTIC WITH UNACIDE 3G I.V. TIME OUT, ANESTHESIA WITH SHORT-ACTING RELAXANT, PADDED PRONE POSITION, STERILE COVERING. CAREFUL MEASUREMENT OF THE LANDMARKS AND RECORDING OF NEUROFORAMINA S3 AND S4, X-RAY FLUOROSCOPY IN THE EXACT LATERAL BEAM PATH FOR POSITION AND DEPTH CONTROL. PIERCING THE NEEDLY ELECTRODES ON BOTH SIDES OF S3, CONTINUOUS TESTING UNTIL WE GET A GOOD ANSWER. BEST RESPONSE TO NEUROFORAMEN S3 LEFT - VERY GOOD SPECIFIC RESPONSE MOTOR THRESHOLD 0.7MA. THEN PHOTO DOCUMENTATION OF THE POSITION OF THE ELECTRODES. THEN THE IMPLANTATION OF THE TINED LEAD ELECTRODES MRI-CAPABLE SYSTEM (SURESCAN), CURVED STYLET: INCISION 1CM IN THE DIRECTION OF THE POCKET, PREPARATION ALONG THE NEEDLE OF THE STYLET IS REMOVED, GUIDEWIRE TO THE MARK ON THE RESISTANCE. INSERTION OF THE TROCAR TO THE MARK ON THE VENTRAL CORTEX OF THE SACRUM. INSERT THE 28MM TINED-LEAD ELECTRODE TO THE FIRST MARK. NO MOTOR RESPONSE. THE X-RAY INSPECTION SHOWS A PERFECT POSITION. RETRACTION OF THE SLEEVE AND

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687287 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION AND URGE INCONTINENCE IT WAS REPORTED THAT THEY WERE RETAINING BIG TIME. PATIENT SAID THEY WERE STILL GETTING UTIS AND WERE ON AN ANTIBIOTIC FOR IT. PATIENT MENTIONED THEY WENT 3 MONTHS WITHOUT A CATHETER BECAUSE IT WAS WORKING AND IT WASN'T WORKING. CALLER STATED THAT THE INS STOPPED WORKING OVER THE SUMMER. CALLER WENT ON TO SAY THAT THEY WERE SOMETIMES STILL RETAINING URINE WHICH IS CAUSING UTIS. CALLER STATED THAT LAST WEEK THEY WERE TAKEN TO THE HOSPITAL AND HAD ANOTHER UTI. CALLER STATED THAT THEY TOOK AN ULTRASOUND OF THE PATIENTS BLADDER AND IT WAS EMPTY , A FEW HOURS LATER THEY TOOK ANOTHER ULTRASOUND AND COULD SEE THAT THE PATIENT WAS RETAINING URINE. CALLER STATED THAT THE THERAPY WAS WORKING INTERMITTENTLY. AGENT ASKED IF PATIENT HAS HAD ANY FALLS OR TRAUMA TO THE AREA AND PATIENT SAID NO. PATIENT STATED THEY HAVE MADE ADJUSTMENTS TO THE STIMULATION ABOUT 5-6 TIMES , EVEN SOMETIMES WITH THE HELP OF TH EIR UROLOGIST. PATIENT CONFIRMED THEY WERE FEELING STIMULATION WHEN THEY ADJUST IT. AGENT REVIEWED THERAPY INFORMATION AND GENERAL PROGRAMMING

  Patient problems: Urinary Retention; Urinary Tract Infection

  MAUDE report 23375386 ↗
• InjuryOct 21, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLAN TED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE DOCTOR TRIED TO PLACE THE TINED LEAD AS ALWAYS. MANUFACTURER REPRESENTATIVE (REP) WAS IN THE OR TOO AND NONE OF THE DOCTOR'S STEPS WHILE THE PROCEDURE WERE WRONG. AFTER DOCTOR PUSHED THE TINED LEAD TROUGH THE PLASTIC CANAL THEY SAW A CRACK AND THE TINED LEAD WASN¿T WORKING ANYMORE SO THEY HAVE TO CHANGE IT WITH ANOTHER ONE. NO CAUSE KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349173 ↗
• InjuryOct 15, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT DURING PROCEDURE, THE ELECTRODE SHOWED WEAKNESS IN THE REPOSITIONING BETWEEN S2 AND S3, CAUSING A FRACTURE IN THE ELECTRODE. NO CAUSE KNOWN. A NEW ELECTRODE HAD TO BE OPENED SINCE THERE WAS NO ENERGY PRESENT, AND THE PROCEDURE OCCURRED WITHOUT COMPLICATIONS AND WITH THE EXPECTED EFFICACY. ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302077 ↗
• MalfunctionAug 27, 2025Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area; Impedance Problem; Therapeutic or Diagnostic Output Failure; Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area; Impedance Problem; Therapeutic or Diagnostic Output Failure

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT/SORENESS/PINCHING. SPOKE TO THE PATIENT (PT) ON (B)(6) 2025. THEY WERE HAVING HIP AND BUTTOCK SENSATION. SHE ALSO WAS LIMITED TO 0.3 MA ON MULTIPLE PROGRAMS INDICATING AN IMPEDANCE ISSUE. REPRESENTATIVE (REP) SENT AN EMAIL TO THE OFFICE THAT THEY MAY NEED AN XRAY TO CHECK THEIR LEAD AS REP INDICATED THERE WAS A LEAD MIGRATION.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions; Undesired Nerve Stimulation

  MAUDE report 22903540 ↗
• InjuryAug 22, 2025High impedance; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; High impedance; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCE. IMPEDANCE WAS OFF IN ALL 4 ELECTRODES, >4000 OHMS. PER PROVIDER OFFICE, XRAY WAS DONE ON (B)(6) 2025 AND WAS COMPARED TO (B)(6) 2025 IMPLANT, THEY OFFER THAT THE LEAD HAS MOVED AS 2 ELECTRODES ARE NOW IN THE SACRUM. THE STATED CAUSE WAS DUE TO A PATIENT FALL. PATIENT SAID THEY HAD A HORRIBLE FALL. THEY FELL ONTO THE RIGHT ARTIFICIAL KNEE. ISSUE WAS NOT RESOLVED AND IS ONGOING. PATIENT TO BE SCHEDULED BEFORE THE END ON THE YEAR FOR A LEAD REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874662 ↗
• MalfunctionJul 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THEY HAD A LACK OF ELECTRODE CONNECTIVITY. THE INITIALLY IMPLANTED ELECTRODE DID NOT OFFER CONNECTIVITY AND THEREFORE DID NOT CONNECT WITH THE TEST CONTROL DURING THE PROCEDURE. NO KNOWN CAUSE. THE ELECTRODE REPLACEMENT WHILE STILL IN THE ROOM. ISSUE RESOLVED. IT WAS IDENTIFIED THAT THERE WAS NO CONNECTIVITY WITH THE ELECTRODE AND WITH THAT A NEW ELECTRODE WAS USED THAT THEN IT WAS POSSIBLE TO COMPLETE THE PROCEDURE. THE SURGERY OCCURRED NORMALLY AFTER THE USE OF ANOTHER ELECTRODE AND EVERYTHING WENT CORRECTLY, WITHOUT HARM TO THE PATIENT. THE ELECTRODE WILL NOT BE RETURNED OR REMOVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22682654 ↗
• MalfunctionJun 27, 2025Break; Positioning Problem; Break; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE LEAD KEPT BENDING UPWARD WHEN IT WAS PLACED. THE DOCTOR TRIED TWISTING THE LEAD TO CHANGE THE ANGLE BECAUSE THEY SAID IT FELT LIKE THE LEAD WAS HITTING SOMETHING. WHEN THEY REMOVED THE LEAD TO REPOSITION ELECTRODE 0 SNAPPED OFF. THEY USED A NEW LEAD AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345121 ↗
• MalfunctionJun 11, 2025Component Missing; Component Missing

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PLASTIC STRAW WASN'T PRESENT IN THE KIT. THE CUSTOMER COULDN'T TUNNEL AND THEY HAD TO OPEN ANOTHER KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181775 ↗
• MalfunctionApr 3, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THIS WAS AN OUT OF BOX ISSUE. THE CAUSE OF THE LEAD BEING FRAYED AND THE RUBBER COMING OFF EXPOSING THE WIRES WAS UNKNOWN. NO STEPS WERE TAKEN TO RESOLVE THIS ISSUE BUT IT WAS REPORTED THAT THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761592 ↗

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