BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 2648158 · Received July 10, 2012

    Report

    Report Number
    3007566237-2012-01589
    Event Type
    Injury
    Date Received
    July 10, 2012
    Date of Event
    June 15, 2012
    Report Date
    June 18, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28 LOT# V012107 SERIAL# IMPLANTED: 2006-(B)(6) EXPLANTED: 2012-(B)(6) PRODUCT TYP LEAD PRODUCT ID 3095-10 LOT# SERIAL# (B)(4) IMPLANTED: 2006-(B)(6) EXPLANTED: 2012-(B)(6) PRODUCT TYP EXTENSION PRODUCT ID 3031A LOT# SERIAL# (B)(4) IMPLANTED: 2006-(B)(6) EXPLANTED: PRODUCT TYP PROGRAMMER, PATIENT PRODUCT ID 3023 LOT# SERIAL# (B)(4) IMPLANTED: 2006-(B)(6) EXPLANTED: 2012-(B)(6) PRODUCT TYP IMPLANTABLE NEUROSTIMULATOR. (B)(4). THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEADS", EDUCATIONAL BRIEF/PHYSICIAN COMMUNICATION (DECEMBER 2010).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE DURING A SURGICAL PROCEDURE. THE LEAD WAS DAMAGED DURING THE EXPLANT PROCEDURE. ON (B)(6) THERE WAS A BATTERY REPLACEMENT DUE TO EOL (END OF SERVICE). MODEL 3023 WAS USED FOR REPLACEMENT AND THEY GOT HIGH IMPEDANCES ON ALL CONTACTS. THEY INCREASED AMP AND PW AND RERAN X2 WITH NO SUCCESS. EVERYTHING WAS DISCONNECTED AND RECONNECTED AND STILL NO SUCCESS. THE PHYSICIAN WAS GOING TO PULL LEAD AT THAT POINT BUT WHEN THEY TRIED TO REMOVE LEAD WITH GENTLE TRACTION AND THEN USING A LEAD INTRODUCER, THE LEAD BROKE AND TINES ARE STILL IN PATIENT. THE PHYSICIAN DID NOT WANT TO DO A CUTDOWN TO RETRIEVE IT AS HE DID NOT HAVE PRIOR PATIENT CONSENT TO DO SO. THE PATIENT HAD GOOD STIM WITH OLD SYSTEM. IT WAS UNKNOWN HOW LONG THE INS WAS DEPLETED. INS/EXT/ LEAD EXCEPT FOR THE TINES ARE EXPLANTED WITH NO IMPLANT AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT WAS DOING WELL AND WAS RECEIVING EFFECTIVE THERAPY. NO ADDITIONAL PROCEDURE WAS NECESSARY TO REMOVE THE TINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention