BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1022767 · Received March 28, 2008

    Report

    Report Number
    3004209178-2008-01691
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    November 1, 2007
    Report Date
    February 28, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED NO OUTPUT OR TELEMETRY, NORMAL EOL. COMPUTER LONGEVITY ESTIMATE WAS 23 MONTHS BASED ON THE DEVICE SETTINGS REPORTED, THE DEVICE LIFE WAS APPROXIMATELY 20 MONTHS BASED ON IMPLANT DATE AND EVENT DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED CESSATION OF THERAPY (SYMPTOMS WERE UNSPECIFIED. THE HCP FELT THAT THE STIMULATOR BATTERY DEPELETED PREMATURELY. THE STIMULATOR WAS REPLACED. NO PATIENT OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention PROGRAMMER MODEL PROGRAMMER LOT# UNK| IMPLANTED:| EXTENSION MODEL 7482 LOT# NHU101590V| EXPLANTED:| IMPLANTED:| LEAD MODEL 3387 LOT# J0537471V| EXPLANTED:| IMPLANTED:| LEAD MODEL 3387 LOT# J0537471V| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION MODEL 7482 LOT# NHU107693V| IMPLANTED: