BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2510094 · Received March 29, 2012

    Report

    Report Number
    3004209178-2012-01966
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Report Date
    March 6, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    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

    (B)(4). LEAD: MODEL 3889-28, LOT# V002972, IMPLANTED: (B)(6) 2006, EXPLANTED UNK; EXTENSION: MODEL 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED UNK; PROGRAMMER: MODEL 3031A, SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION IN THE LEFT LEG AND FOOT. IT WAS ALSO REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR WAS "ACTING FUNNY" IN (B)(6) 2011. THE PATIENT WAS REPROGRAMMED. IT WAS NOTED THE PATIENT ONLY TURNED HER IMPLANTABLE NEUROSTIMULATOR ON AT NIGHT TO ENSURE SHE HAS AN EMPTY BLADDER. A MANUFACTURER REPRESENTATIVE REPROGRAMMED THE DEVICE ON (B)(6) 2012 AND THE ISSUE HAD RESOLVED ACCORDING TO PHYSICIAN RECORDS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S STIMULATION WAS NOT WORKING FOR HER. SHE HAD AN APPOINTMENT SCHEDULED FOR (B)(6)-2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1