BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2120157 · Received June 6, 2011

    Report

    Report Number
    3004209178-2011-04010
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    February 1, 2011
    Report Date
    May 26, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO, THE PT HAD RECONSTRUCTIVE SURGERY ON HIS URETHRA AND IT WAS DECIDED NOT TO RE-IMPLANT ANOTHER DEVICE SYSTEM. PT HAD HAD A DEVICE FOR (B)(6). SINCE (B)(6), HE HAD BEEN HAVING ISSUES WITH HIS URINARY TRACT NERVES AND WAS SEEING A PSYCHOLOGIST. THE PSYCHOLOGIST TOLD THE PT, HE WAS EXPERIENCING RESIDUAL EFFECT AND NEEDED TO GO ON DRUG THERAPY TO CALM THE NERVES AND GET RID OF THE EFFECT OF STIMULATION. PT SYMPTOMS WERE ACUTE PAIN AND DISCOMFORT THAT FEELS LIKE THE STIMULATION WAS STILL ON. PT STATED HE WAS JUMPY AND HAD ISSUES IN THE SCROTUM. WHEN HE WAS ASLEEP, HE DID NOT HAVE PROBLEMS. ADDITIONAL INFO FROM THE HCP REPORTED THERE WERE NO DEVICE ISSUES. THE PT UNDERWENT DEVICE EXPLANT BECAUSE HE HAD URETHRAL STRICTURES WHICH HAD NOT BEEN RECOGNIZED OR TREATED BY THE SURGEON WHO PLACED THE DEVICE. REFERENCE MFR REPORT # 3004209178-2011-04009 FOR RELATED INS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention IMPLANTABLE PULSE GENERATOR: MODEL 3023,| IMPLANTED:| LOT# NBV126743H| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD077318N| LEAD: MODEL 3093, LOT# V238901| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 3095, LOT# NAH016782V| PROGRAMMER: MODEL 3031A, LOT# NGM004704P| LEAD: MODEL 3093, LOT# J0455369V| IMPLANTED: