BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2510072 · Received March 29, 2012

    Report

    Report Number
    3004209178-2012-01965
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Report Date
    March 21, 2012
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 BEGAN EXPERIENCING INTERMITTENT STIMULATION AND A LOSS OF THERAPEUTIC EFFECT A FEW WEEKS PRIOR TO (B)(6) 2006. THE PATIENT HAD ALSO BEEN DIAGNOSED WITH ADDITIONAL UROLOGICAL CONDITIONS, AND HAD NOT RECEIVED A DEVICE ADJUSTMENT SINCE IMPLANT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IN (B)(6) 2006, THE PATIENT EXPERIENCED LEFT BUTT PAIN OVER THE SITE OF THE IMPLANTABLE NEUROSTIMULATOR. NO INFECTION WAS NOTED, AND THE PAIN RESOLVED WITH PATIENT REPOSITIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1