BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2473310 · Received February 29, 2012

    Report

    Report Number
    3004209178-2012-01273
    Event Type
    Injury
    Date Received
    February 29, 2012
    Date of Event
    May 11, 2010
    Report Date
    June 25, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXTENSION MODEL 748240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2011; EXTENSION MODEL 748240, SERIAL #(B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2011; LEAD MODEL 3387S-40, LOT # V010322, IMPLANTED: (B)(6) 2007, EXPLANTED: NA; LEAD MODEL 3387S-40, LOT # V010322, SERIAL # UNK, IMPLANTED: (B)(6) 2007, EXPLANTED: NA. THIS DEVICE WAS BEING USED IN A CLINICAL TRIAL NOTED AS (B)(4). ANALYSIS OF NEUROSTIMULATOR 7428, SERIAL #(B)(4) SHOWED NO SIGNIFICANT ANOMALIES, WAS AT NORMAL END-OF-LIFE (EOL). ANALYSIS OF BOTH RETURNED EXTENSIONS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POSSIBLE FRACTURE OF THE LEFT EXTENSION. IT WAS NOTED THAT THE PATIENT SUFFERED A GENERALIZED SEIZURE ON (B)(6) 2010 WHICH, IN THE PAST, HAD RESULTED IN A "FRACTURED LEAD." INTERROGATION OF THE IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM ON (B)(6) 2010 SHOWED IMPEDANCES OF >4000 OHMS ON THE LEFT SIDE (ELECTRODE 2). X-RAYS SHOWED NO EVIDENCE OF A BREAK OR KINK IN THE LEADS. THE PHYSICIAN WAS GOING TO WAIT AND SEE IF THE PATIENT HAD ANY DECREASE IN THERAPY EFFECTIVENESS (SEIZURES). IT WAS ALSO NOTED THAT THE PATIENT WAS NOT ANXIOUS TO HAVE A FURTHER SURGERY SINCE SHE HAS NOW HAD "SEVERAL SURGERIES." IT WAS SUBSEQUENTLY REPORTED THAT THE PATIENT HAD THE INS REPLACED DUE TO NORMAL BATTERY DEPLETION AND AT THE SAME TIME BOTH OF THE EXTENSIONS WERE REPLACED. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR Required Intervention