BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2944051 · Received February 5, 2013

    Report

    Report Number
    3004209178-2013-01310
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    January 16, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28 LOT# V386950, IMPLANTED: 2010 (B)(4), PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT "HAD TO GO BACK BECAUSE SOME WIRES WEREN'T RIGHT" A FEW MONTHS BACK. THE REPORTER INDICATED THAT "IT WASN'T WORKING VERY WELL". THE REPORTER DIDN'T KNOW IF ONE OF THE WIRES "WASN'T WORKING OR SOMETHING". NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT LATER REPORTED THAT SHE WOULD BE HAVING A REVISION AS SOMETHING WAS NOT WORKING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS NOT DETERMINED. TWO OF FOUR ELECTRODES HAD HIGH IMPEDANCES. REPROGRAMMING WAS DONE. A NEW LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS) WERE IMPLANTED. THE PATIENT HAD A 50 PERCENT OR GREATER SYMPTOMS REDUCTION AND THEY HAD RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48467 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention