BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3033064 · Received April 3, 2013

    Report

    Report Number
    6000032-2013-00079
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# (B)(4), IMPLANTED: 2001-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: 2001-(B)(6), PRODUCT TYPE EXTENSION, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT GAINED 100 POUNDS AFTER THE DEVICE WAS IMPLANTED AND "IT SHIFTED." IT WAS ALSO REPORTED THE PATIENT WAS UNCERTAIN IF THE IMPLANTABLE NEUROSTIMULATOR (INS) OR THE LEAD HAD SHIFTED. IN 2006 OR 2007, THE HEALTHCARE PROVIDER REVISED THE POCKET SITE AND MOVED THE PATIENT'S INS TO THE LEFT SIDE OF THE PATIENT'S BODY. IT WAS REPORTED THAT FIVE MONTHS AFTER THE REVISION THE INS BATTERY "DIED" AND NEEDED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136305 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT SOFAMOR DANEK PUERTO RICO MFG 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention