BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2073618 · Received April 27, 2011

    Report

    Report Number
    3004209178-2011-03120
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    May 27, 2007
    Report Date
    April 8, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL 3 DAYS POST IMPLANT. ANOTHER NEUROSTIMULATOR SYSTEM WAS THEN IMPLANTED BECAUSE OF THE DAMAGE TO THE FIRST SYSTEM FROM THE FALL. SUBSEQUENTLY, THE PATIENT EXPERIENCED A "HOT" SENSATION ON HER RIGHT NEUROSTIMULATOR SITE FOR 6 MONTHS IN 2008. SHE VISITED ANOTHER PHYSICIAN IN 2009 AND WAS TREATED WITH BROAD SPECTRUM ANTIBIOTICS WITH THE RESULT THAT THE HOT SENSATION RESOLVED. SHE ALSO HAD FREQUENT URINARY TRACT INFECTIONS AND HER PHYSICIAN WAS TRYING TO FIGURE OUT THE CAUSE. IT WAS NOTED THAT SHE HAD NOT FELT STIMULATION ON HER LEFT SIDE FOR "YEARS." HER PATIENT PROGRAMMER WAS FOUND TO HAVE BATTERY ACID DAMAGE DUE TO LEAVING THE BATTERIES IN WITH CORROSION ON THE CONTACTS AND WAS REPLACED. ADDITIONAL INFORMATION WAS REQUESTED. SEE MANUFACTURER'S REPORT # 3004209178201103121.

    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 74 YR Required Intervention PROGRAMMER: MODEL 3037, LOT# NJD037298N| LEAD: MODEL 3093, LOT# V015099| LOT#NJY108515H| PROGRAMMER: MODEL 3037, LOT# NJD057386N| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# V063416| IMPLANTABLE NEURO STIMULATOR: MODEL 3058,