BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA RC

    MDR report key: 1841967 · Received September 21, 2010

    Report

    Report Number
    3004209178-2010-07126
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 26, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PATIENT HAD EXPERIENCED A SHOCKING SENSATION A COUPLE TIMES A WEEK ON THEIR LEFT SIDE. IT WAS NOTED THAT THE PT PREVIOUSLY UNDERWENT A DEVICE REPLACEMENT SURGERY TWO WEEKS FROM (B)(6) 2010. AN IMPEDANCE CHECK SHOWED A SHORT ON CONTACTS 8 AND 9. A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2010 TO CORRECT THE ISSUE. FOLLOWING THE SCHEDULED REVISION, THE PT PROGRAMMER WAS NOTED TO HAVE AN ISSUE. THE PT PROGRAMMER LIGHTS ON THE BACKSIDE WERE ALL LIT, AND IT WAS NOTED THEY WOULD NOT GO OUT. IT WAS FURTHER REPORTED THAT THE BUTTONS DID NOT APPEAR TO BE STUCK, AND THE BATTERY WAS CHANGED WITH NO EFFECT. A REPLACEMENT PROGRAMMER WAS REQUESTED. THE PT WAS NOTED AS BEING FINE WITH THE PLAN FOR PROGRAMMER REPLACEMENT, AND HAD NO ILL EFFECTS FROM ISSUE. ADD'L INFO IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A F/U REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA RC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37612 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention IMPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ105725N| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT# L85844| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| SN# (B)(4)| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37651, LOT# NKA136985N| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| SN# (B)(4)| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN008508V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-66, LOT# XS0006181N| IMPLANTED: