BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2951393 · Received February 9, 2013

    Report

    Report Number
    6000032-2013-00036
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    January 23, 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
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S DEVICE WAS "BOTHERING" HER AND SHE WANTED IT REMOVED. THE REPORTER DID NOT PROVIDE SPECIFIC DETAILS ABOUT ANY ISSUES WITH DEVICE. IT WAS STATED THAT THE PATIENT HAS HAD THE DEVICE FOR OVER 7 YEARS, AND IT HAD NOT WORKED "IN A LONG TIME". FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56983 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT SOFAMOR DANEK PUERTO RICO MFG 3023

    Patients

    Seq Age Sex Outcome Treatment
    1