BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 8590452 · Received May 8, 2019

    Report

    Report Number
    3004209178-2019-09100
    Event Type
    Injury
    Date Received
    May 8, 2019
    Date of Event
    April 30, 2019
    Report Date
    August 12, 2019
    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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION 'CONCOMITANT MEDICAL PRODUCTS' INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28, LOT# V896802, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# V896802, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. EVAL CODE METHOD AND EVAL CODE-RESULT APPLY TO LEAD (LOT#V896802) ONLY. ANALYSIS: ANALYSIS OF THE LEAD (LOT#V896802) FOUND THE OUTER INSULATION OF THE LEAD WAS SEPARATED IN THE BODY OF THE LEAD AT A BUTT JOINT AT THE PROXIMAL END OF THE LEAD; THIS IS CONSISTENT WITH EXPLANT DAMAGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28,,LOT# V896802, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2019,PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THERE WAS NO MOTOR RESPONSE WITH THE LEAD DURING BATTERY REPLACEMENT. IT WAS NOTED THE BATTERY WAS BEING REPLACED DUE TO NORMAL DEPLETION. DURING THE PROCEDURE THEY HAD INCREASED THE AMPLITUDE TO GAIN MOTOR RESPONSE AND NONE WAS OBSERVED. CONTRIBUTING FACTORS WERE UNKNOWN. THEY REPLACED THE LEAD AND GOT GOOD MOTOR RESPONSE, THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    NO NEW INFORMATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) VIA A HEALTHCARE PROVIDER (HCP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. PATIENT REPORTED A "POWER SURGE" WHICH FELT LIKE A SHOCKING SENSATION FOR ABOUT FIVE MINUTES AND THEN DIDN'T FEEL THE SENSATION AT ALL. THE PATIENT THEN NOTED A POWER ON RESET (POR) AND ALL OF THEIR SYMPTOMS WERE RETURNING (URINARY FREQUENCY). NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS WERE NOTED. NO DIAGNOSTICS/TROUBLESHOOTING WAS PERFORMED. THE PATIENT IS PLANNING TO SCHEDULE AN APPOINTMENT WITH THEIR HCP. SURGICAL INTERVENTION DID NOT OCCUR, BUT IT IS PLANNED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) WHO CONFIRMED THE INFORMATION WITH THE HEALTHCARE PROVIDER (HCP). THE REP NOTED THE ACCOUNT RETAINED THE INS "PER THE ACCOUNT PROTOCOL TO ASSESS FOR GROWTH". NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383461 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention