BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2694298 · Received August 13, 2012

    Report

    Report Number
    3004209178-2012-06837
    Event Type
    Injury
    Date Received
    August 13, 2012
    Report Date
    July 15, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD MODEL 3389S-40, LOT # V050963, IMPLANTED: (B)(6) 2007, EXPLANTED: NA; LEAD MODEL 3389S-40, LOT # V050963, IMPLANTED: (B)(6) 2007, EXPLANTED: NA; EXTENSION MODEL 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: NA; EXTENSION MODEL 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PREVIOUS INS MALFUNCTIONED AND HIS SYMPTOMS "CAME BACK WITH A VENGEANCE." THE PATIENT EXPERIENCED GOOD THERAPY WITH HIS CURRENT SYSTEM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS THAT THE BATTERY HAD "EXHAUSTED." THIS WAS INDICATED AS NORMAL BATTERY DEPLETION. IT WAS ALSO NOTED THAT HOSPITALIZATION WAS NEEDED DUE TO THE EVENT. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE CAUSE OF THE EVENT WAS BATTERY FAILURE/DEPLETION. EXPLANT DATE WAS UNKNOWN BUT SURGICAL INTERVENTION OCCURRED ON (B)(6)-2012 AND A NEW BATTERY WAS IMPLANTED. PATIENT OUTCOME WAS DESCRIBED AS "GOOD." THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention