BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA RC

    MDR report key: 2113752 · Received June 2, 2011

    Report

    Report Number
    3004209178-2011-03935
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 4, 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
    MN, 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 CHARGING THE DEVICE MORE THAN EXPECTED. THE PT CHARGED EVERY DAY, FOR ONE HOUR. THE RECHARGER ESTIMATED THAT THE REMAINING BATTERY LIFE WAS TWO AND ONE-HALF DAYS. THERE WERE LOW IMPEDANCE VALUES FOUND ON ALL OF THE BIPOLAR PAIRS WITH ELECTRODES 8-11. ALL MEASUREMENTS WERE BETWEEN 59 AND 65 OHMS. THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS LATER REPORTED THAT THE PT'S EXTENSION WAS DISCOVERED TO BE DAMAGED, BASED ON THE LOW IMPEDANCE READINGS. THE EXTENSION WAS REPLACED. THE PT DID NOT REPORT ANY OTHER SYMPTOMS. NO INFO WAS PROVIDED RELATED TO THE PT'S OUTCOME. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO 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 45 YR Required Intervention LEAD: MODEL 3387, LOT# J0405899V| EXPLANTED:| RECHARGER: MODEL 37651, LOT# NKA146843N| LEAD: MODEL 3387, LOT# J0421701V| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN014549V| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN014141V| IMPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ111441N| IMPLANTED:| IMPLANTED: