BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 2250623 · Received September 9, 2011

    Report

    Report Number
    3004209178-2011-07668
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 17, 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 EITHER A REVISION OR REPLACEMENT DUE TO HIS IMPLANTABLE NEUROSTIMULATOR (INS) MOVING UNDER HIS (B)(6). IT WAS UNK IF THE PT HAD THE INS RELOCATED OR REPLACED. 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. SEE ALSO MFR REPORT #3004209178-2011-07669. IN ADDITION, SEE MFR REPORTS # 3004209178-2011-07671 AND 3004209178-2011-07673 FOR PRIOR 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 EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0025764N| IMPLANTABLE NEURO STIMULATOR: MODEL 37601,| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN011508V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT# V042082| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3382, LOT# L33314| LOT# NKM706369H| IMPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ107295N| EXPLANTED: