BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2866977 · Received December 11, 2012

    Report

    Report Number
    3004209178-2012-11394
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Report Date
    November 15, 2012
    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
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT # V623317, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 355018, LOT # W59955, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 041829, LOT # N272716, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE TELEMETRY ISSUES. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS UNRESPONSIVE TO TELEMETRY ATTEMPTS WITH THE PHYSICIAN PROGRAMMER, PATIENT PROGRAMMER AND THE RECHARGER. IT WAS ALSO NOTED THE PATIENT HAD NO STIMULATION SENSATION AND A LOSS OF THERAPEUTIC EFFECT. X-RAYS INDICATED THE LEAD WAS IN THE CORRECT LOCATION. IT WAS ALSO NOTED THE PATIENT HAD LOST THEIR PATIENT PROGRAMMER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1