BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3451980 · Received November 6, 2013

    Report

    Report Number
    3004209178-2013-20268
    Event Type
    Injury
    Date Received
    November 6, 2013
    Report Date
    September 16, 2011
    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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3387S-40, LOT# V020895, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V020895, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4). ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND THE BATTERY WAS NOT IN NEW CONDITION. FOREIGN MATERIAL WAS SEEN IN CONNECTOR PORTS #6 AND #7. INS OUTPUT WAS TESTED AT THE DISTAL END OF A KNOWN GOOD EXTENSION. GOOD, STABLE OUTPUT WAS OBSERVED ON EACH ELECTRODE PAIR ON AN OSCILLOSCOPE, ACROSS A 510 OHM LOAD, CONNECTED TO THE DISTAL END OF THE EXTENSION. POWER ON RESET HAD OCCURRED PRIOR TO ANALYSIS. PUNCHOUT HOLES IN SETSCREW GROMMETS #6 AND #7. THERE WAS FOREIGN MATERIAL (SUSPECTED BODY FLUID) IN THE SETSCREW PORT UNDER THE GROMMETS. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE THERAPY THE DEVICE WAS USED FOR WAS EPILEPSY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED NEUROSTIMULATOR POCKET DISCOMFORT AND VIBRATION IN THE NECK. IT WAS NOTED THE EVENT DATE OF THE DISCOMFORT WAS (B)(6) 2010 AND (B)(6) 2010 FOR THE VIBRATION IN THE NECK DUE TO THE EXTENSION TRACT. IT WAS ALSO NOTED THE PATIENT¿S ¿DBS WAS NOT WORKING.¿ THE PATIENT¿S NEUROSTIMULATOR WAS REPLACED ON (B)(6) 2011 DUE TO BATTERY DEPLETION AND IT WAS REPORTED THE PATIENT RECOVERED WITHOUT SEQUELAE AFTER THE NEUROSTIMULATOR WAS REPLACED. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE WITH A RESOLUTION DATE OF (B)(6) 2013 AND SYMPTOMS WERE ALLEVIATED WHEN WEARING A SPORTS BRA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT OUTCOME WAS RESOLVED WITHOUT SEQUELAE ON 2014-(B)(6). IT WAS NOTED THE INTERVENTION, DIAGNOSTIC METHOD, ETIOLOGY, AND SEVERITY WERE NO CHANGE. IT WAS FURTHER NOTED THAT THERE WERE NO NEW SIGNS AND SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572772 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention