BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3179832 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-10637
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: NO SIGNIFICANT ANOMALIES FOUND. IT WAS STATED THE DEVICE FUNCTIONED PROPERLY THROUGHOUT THE DURATION OF THE TEST. THE INS WAS FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3889-28, LOT# V802404, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INTERMITTENT STIMULATION. THE PATIENT WENT ¿DAYS¿ WITHOUT FEELING STIMULATION BUT THE DEVICE WAS CONTROLLING HER LEAKAGE. IT DID NOT MATTER WHAT POSITION OR ACTIVITY THE PATIENT WAS IN, THE STIMULATION WAS INTERMITTENT. THE PATIENT NOTED THAT SHE ¿COULD BE STANDING, TALKING TO SOMEONE¿ AND THE STIMULATION ¿WOULD COME BACK ON STRONGLY.¿ THE PATIENT STATED THAT IT WAS UNCOMFORTABLE WHEN THAT HAPPENED. THE STIMULATION HAD BEEN THIS WAY SINCE IMPLANT. THE PATIENT HAD A LEAD REVISION ON (B)(6) 2013 AND THERE WERE NO CHANGES TO THE INTERMITTENT STIMULATION SINCE THEN. IT WAS MENTIONED THAT IMPEDANCES WERE CHECKED AND IMAGING WAS DONE BEFORE THE LEAD REVISION. NO RESULTS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STILL HAD SOME LEAKAGE BUT WAS LEAKING LESS THAN THEY WERE PRIOR TO THE IMPLANT. IT WAS NOTED THAT THE IMPEDANCES WERE FINE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT NOTED A CHANGE IN BENEFIT OF THEIR DEVICE ON THEIR OFFICE VISIT ON (B)(6) 2013. IT WAS STATED THE PATIENT HAD A SHOCKING SENSATION AT THAT TIME AND PINS AND NEEDLES INTO THE LABIA. IT WAS NOTED THERE WERE MULTIPLE MONOPOLAR AND BIPOLAR PROGRAMS TRIALED WITH NO BENEFIT. SO, THE PATIENT HAD A LEAD REVISION ON (B)(6) 2013 BUT HAD NO PERSISTENT IMPROVED BENEFIT. IT WAS STATED THE PATIENT HAD INTERMITTENT STIMULATION THAT WAS UNPREDICTABLE AND WAS NOT CYCLING. IT WAS NOTED THIS CAUSED SHOCKING AND PINS AND NEEDLES IN THE LABIA. IT WAS STATED IT WOULD SHUT OFF AS WELL. IT WAS REPORTED THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED ON (B)(6) 2014 AND THE LEAD WAS PRISTINE AND THERE WAS NO FLUID NOTED IN THE LEAD. REPORTEDLY, THE DEVICE WAS NOT REMOVED FOR NORMAL BATTERY DEPLETION AND IT WAS REMOVED DUE TO CAUSING A SHOCKING SENSATION. IT WAS NOTED THE PATIENT HAD THERAPY IN THE APPROPRIATE LOCATION IN THE BIKE SEAT AREA. IT WAS STATED THE PATIENT HAD NO INJURY AND RECOVERED WITHOUT SEQUELAE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280582 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention