BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 2220219 · Received August 16, 2011

    Report

    Report Number
    3004209178-2011-06434
    Event Type
    Injury
    Date Received
    August 16, 2011
    Report Date
    July 25, 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
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED PULLING AT THE EXTENSION THAT WAS "UNBEARABLE" TO THE POINT THAT THE PT WANTED THE IMPLANT REMOVED EVEN THOUGH IT WAS HELPING HER SYMPTOMS. THE PT'S HUSBAND STATED THAT THE PULLING WAS SO SEVERE IT WAS PULLING THE IMPLANTABLE NEUROSTIMULATOR UPWARDS AS WELL. THE HEALTH CARE PROVIDER HAD PERFORMED TWO REVISIONS OF THE EXTENSION AND COULD NOT FIND ANY SOURCES OF THE PULLING. THE PULLING BEGAN 2-3 MONTHS AGO, AND THERE WAS NO KNOWN INCIDENT ASSOCIATED WITH IT. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 Required Intervention EXTENSION: MODEL 37085, LOT# NKN014213V| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN007653V| PROGRAMMER: MODEL 37642, LOT# NJZ109634N| LEAD: MODEL 3387S, LOT# V526048| IMPLANTED:| EXPLANTED:| IMPLANTED: