BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3120168 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07892
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 30, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE STIMULATOR, SERIAL (B)(4), FOUND IT FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V498749, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) KEPT ¿SHUTTING OFF ON ITS OWN¿. THE DEVICE WAS THEN EXPLANTED. THERE WAS NO PATIENT INJURIES REPORTED WITH THE EVENT. FOLLOW UP INFORMATION RECEIVED REPORTED THAT IT WAS UNKNOWN AS TO THE EXACT DATE OF ONSET OF THE DEVICE SHUTTING OFF ISSUE BUT IT WAS NOTED BY THE PATIENT THAT IT HADBEEN GOING ON FOR A FEW MONTHS. NOTHING FURTHER HAD BEEN HEARD FROM THE PATIENT WHICH THOUGHT TO BE A GOOD SIGN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222512 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention