BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4210456 · Received October 29, 2014

    Report

    Report Number
    3004209178-2014-20597
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    October 9, 2014
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# V594488, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ¿LEADS WERE SHATTERED¿ AND HAD IMPEDANCES OVER 4,000 OHMS. AS FAR AS THE MANUFACTURER REPRESENTATIVE KNEW THE PATIENT WAS DOING WELL WITH THE THERAPY UNTIL THE LEAD ¿SHATTERED¿ FROM AN UNKNOWN CAUSE. THE PATIENT DID NOT KNOW WHAT COULD HAVE HAPPENED AS SHE HAD NOT FALLEN. SHE DID HAVE OTHER SURGERIES, INCLUDING ONE FOR A PERFORATED COLON, BUT THE DOCTOR REPORTEDLY STATED THAT THESE COULD NOT HAVE DAMAGED THE LEAD. THE PATIENT HAD ¿A VERY BAD SPRING WITH SOME SERIOUS HEALTH PROBLEMS, BUT THERAPY WAS NOT GOOD LAST (B)(6).¿ SHE HAD BIG PROBLEMS WITH THE THERAPY NOT WORKING WELL THAT HAD BEEN OCCURRING ALL OF 2014. THE PATIENT STATED THAT SHE ¿HAD A BAD DEVICE AND LEADS AND EVERYTHING.¿ SHE STATED THAT ¿IT STOPPED WORKING AND THE BATTERY ENDED UP GOING BAD.¿ THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD NOT BEEN WORKING FOR A WHILE ¿BECAUSE OF THE LEADS AND THERE WERE AMPLITUDE PROBLEMS.¿ A WHOLE NEW DEVICE WAS IMPLANTED ON THE DAY OF THE REPORT. NO PATIENT OUTCOME WAS REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE ON (B)(6) 2014 AND THEIR CONCERNS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691717 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention