BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6074514 · Received November 2, 2016

    Report

    Report Number
    3004209178-2016-23099
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    March 28, 2012
    Report Date
    March 28, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD ALSO RETURNED AND INCLUDED IN REPORT WITH SAME CODING AS INS. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V896640, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. FINAL ANALYSIS OF THE IMPLANTABLE NUEROSTIMULATOR (SERIAL# (B)(4)) REVEALED NO SIGNIFICANT ANOMALY. THERE WAS NO EVIDENCE OF INTERNAL MECHANISM FOR PREMATURE BATTERY DEPLETION WAS FOUND DURING DESTRUCTIVE BATTERY ANALYSIS. FINAL ANALYSIS OF THE LEAD (LOT # V896640) REVEALED NO SIGNIFICANT ANOMALY. IT WAS NOTED THAT THE STIM LEAD BODY CUT THROUGH. (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT TOLD THE REP THAT THERAPY NEVER WORKED AND THAT IT WAS HURTING.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE DEVICE NEVER WORKED FOR PATIENT SINCE IT WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED AS THE MANUFACTURING REPRESENTATIVE REPORTED THAT DEVICE WAS BEING EXPLANTED TODAY AND WOULD BE SENT BACK TO MEDTRONIC. THE PATIENT INDICATED THAT THE THERAPY NEVER WORKED FOR THEM AND THEY WOULD LIKE IT ANALYZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725075 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention