BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2161996 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-05322
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    April 19, 2011
    Report Date
    June 17, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS OF THE NEUROSTIMULATOR (MODEL 3020, SERIAL# (B)(4)) FOUND NO ANOMALY. THE DEVICE WAS FUNCTIONALLY OKAY. GOOD, STABLE OUTPUT WAS OBSERVED ON EACH ELECTRODE PAIR. ANALYSIS OF THE LEAD (MODEL 3889, LOT# V006652) FOUND CONDUCTOR WIRES 2 AND 3 WERE BROKEN 4.1 CM AND 4.2 CM FROM THE DISTAL END AT TINES. CONTINUITY WAS ACCEPTABLE ON CIRCUITS 0 AND 1; CIRCUITS 2 AND 3 WERE OPEN. ANALYSIS OF THE EXTENSION (MODEL 3095, SERIAL# (B)(4)) FOUND NO ANOMALY. GOOD, STABLE OUTPUT WAS OBSERVED ON EACH ELECTRODE PAIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNDESIRABLE CHANGE IN STIMULATION SENSATION. WHEN THE NEUROSTIMULATOR WAS INTERROGATED, THE PATIENT DID NOT NOTICE ANY STIMULATION. THE PATIENT ALSO EXPERIENCED PAIN AT THE DEVICE OR LEAD SITE, AND FELT DISCOMFORT WHEN SHE SAT DOWN. WHEN THE DEVICE WAS INTERROGATED A MALFUNCTION WAS SUSPECTED. THE PATIENT REQUESTED THE DEVICE BE REMOVED. THE NEUROSTIMULATION SYSTEM WAS EXPLANTED AND REPLACED ON (B)(6)-2011. NO PATIENT INJURY OCCURRED. THE PATIENT'S STATUS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention IMPLANTED:| LEAD: MODEL 3889, LOT# V006652| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3031A, LOT# NGM027417P| EXTENSION: MODEL 3095, LOT# NAH030969V