BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 2250645 · Received September 9, 2011

    Report

    Report Number
    3004209178-2011-07671
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 18, 2011
    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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A REVISION (B)(6) PRIOR DUE TO HIS IMPLANTABLE NEUROSTIMULATOR (INS) MOVING UNDER HIS (B)(6). THE PT EXPERIENCED A SHOCKING SENSATION FROM HIS INS WHILE HE WAS DRIVING, AND HIS BATTERY PACK MOVED NEXT TO THE OTHER BATTERY PACK AT WHICH TIME HE WAS "SHOCKED IN HIS FACE." ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT IF INFO BECOMES AVAILABLE. IN ADDITION, SEE MFR REPORTS #3004209178-2011-07668 AND 3004209178-2011-07669 FOR SUBSEQUENT REVISION ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3387S, LOT# V042082| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3382, LOT# L33314| EXPLANTED:| IMPLANTED:| LOT# NKM706369H| EXTENSION: MODEL 37085, LOT# NKN011508V| PROGRAMMER: MODEL 37642, LOT# NJZ107295N| EXTENSION: MODEL 7495, LOT# XR0025764N| IMPLANTABLE NEURO STIMULATOR: MODEL 37601,| IMPLANTED:| IMPLANTED: