BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2390680 · Received December 28, 2011

    Report

    Report Number
    3004209178-2011-10095
    Event Type
    Injury
    Date Received
    December 28, 2011
    Report Date
    December 7, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3387S, SERIAL #(B)(4), IMPLANTED: 2007-(B)(6), EXPLANTED: UNKNOWN, LEAD MODEL 3387S, SERIAL # (B)(4), IMPLANTED: 2007-(B)(6), EXPLANTED: UNKNOWN, EXTENSION MODEL 748251, SERIAL # (B)(4), IMPLANTED: 2007-(B)(6), EXPLANTED: UNKNOWN, EXTENSION MODEL 748251, SERIAL # (B)(4), IMPLANTED: 2007-(B)(6), EXPLANTED: UNKNOWN.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V011938, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V011938, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PULSING SENSATION AND IMPLANTABLE NEUROSTIMULATOR MIGRATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE NEUROSTIMULATOR WAS REPLACED ON (B)(6) 2012 AND THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED SIGNS AND SYMPTOMS INCLUDED PULSING UNDER NEUROSTIMULATOR (POCKET AREA) AND BATTERY MIGRATION. NO ACTIONS OR INTERVENTIONS WERE REQUIRED AND THE SEVERITY WAS MILD. THE PATIENT'S STATUS WAS UNDETERMINED AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED ON (B)(6) 2012.

    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 00046 YR Required Intervention