BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA RC

    MDR report key: 2200848 · Received August 8, 2011

    Report

    Report Number
    3004209178-2011-06123
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 12, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT HAD AN APPOINTMENT ON (B)(6) 2011. THE PT REPORTED REQUIRING A REPLACEMENT STIMULATOR. THE DEVICE LASTED LESS THAN 23 MONTHS. ON (B)(6) 2011,THE PT REPORTED BREAKING A RIB AS A RESULT OF LACK OF BALANCE. THE PT REPORTED HANDICAPPED MOBILITY, SLURRED SPEECH, FEAR OF FALLING AS WELL AS HEAD NODS (YES, YES). MORE THAN ONE HCP HAD TOLD PT THAT PHYSICAL DETERIORATION WAS PERMANENT AND IRREVERSIBLE. 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 RC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37612 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention ADAPTER: MODEL 64001, LOT #N271212| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37642, LOT #NJZ112210N| EXTENSION: MODEL 37081, LOT #NJB094086V| EXPLANTED:| ADAPTER: MODEL 64001, LOT #N271212| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT #V207484| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37651, LOT #NKA149642N| IMPLANTED: