BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3416782 · Received October 17, 2013

    Report

    Report Number
    3004209178-2013-19279
    Event Type
    Injury
    Date Received
    October 17, 2013
    Report Date
    September 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3093-33 LOT# V013192, IMPLANTED: 2007 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE INS WORKED WELL FOR HER SYMPTOMS BUT A FEW MONTHS PRIOR TO EXPLANT, THE PATIENT WAS REALLY SORE AT THE INS SITE AND HAD PAIN ON HER RIGHT SIDE WHERE THE INS WAS. THE PAIN WAS THE REASON THE PATIENT HAD THE INS EXPLANTED ON 2013-(B)(6). THE PATIENT WANTED TO DONATE THE PROGRAMMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECENTLY HAD THE SYSTEM EXPLANTED DUE TO ONGOING PAIN DOWN HER LEG FOR A COUPLE YEARS PRIOR TO REPORT, AS WELL AS RECENT PAIN AROUND THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE FOR THE PAST 6 MONTHS PRIOR TO REPORT. IT WAS STATED THE PATIENT WAS RIDING A STATIONARY BIKE AND FELT LIKE THAT MIGHT HAVE STARTED THE INS SITE PAIN. IT WAS ALSO STATED, THE PAIN IN HER LEG AND THE RECENT PAIN AT THE INS SITE WERE PRESENT WHETHER STIMULATION WAS ON OR OFF. IT WAS NOTED THE PATIENT FELT THAT ¿THE STIMULATION WORKED AS WELL AS IT COULD FOR HER SITUATION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532687 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention