BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3484097 · Received November 22, 2013

    Report

    Report Number
    3004209178-2013-21313
    Event Type
    Injury
    Date Received
    November 22, 2013
    Report Date
    November 19, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# V840299, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# NJD138274N, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) HAD A LOW BATTERY. IT WAS STATED THE LOW BATTERY WARNING WAS SEEN BY THE CLINICIAN AND THE CAPACITY WAS 0-1 PERCENT. IT WAS NOTED FOR THE LAST MONTH THE CLINICIAN HAD CHANGE THE PULSE WIDTH FROM 210 TO 300. REPORTEDLY, THE PATIENT HAD A RETURN OF SYMPTOMS NIGHT AND DAY AND WAS LEAKING ALL THE TIME. IT WAS STATED HIGHER VALUES WERE PREVIOUSLY PROGRAMMED BUT THE TIME FRAME WAS UNKNOWN. IT WAS NOTED THE CLINICIAN WOULD TRY TO PROGRAM FOR THERAPY UNTIL THE REPLACEMENT. IT WAS LATER REPORTED THE PATIENT HAD THEIR BATTERY REPLACED ABOUT A MONTH PRIOR TO REPORT. WHEN THE REPORTER WAS ASKED IF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED DUE TO NORMAL BATTERY DEPLETION THEY SAID "YEAH, WELL I'M JUST GUESSING. SHE ONLY HAD THAT ONE IN ABOUT A YEAR AND IT WAS DEAD, SO I THINK THEY HAD JUST DETERMINED IT WAS JUST A BAD BATTERY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609287 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention