BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2873896 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-11843
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 23, 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
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3387S-40, LOT# V135050, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3387-40, LOT# J0555411V, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS BITTEN AND PUNCHED IN HIS IMPLANTABLE NEUROSTIMULATOR (INS) LOCATIONS. IT WAS STATED THAT HIS HEALTHCARE PROVIDER (HCP) NOW HAD TO DO SURGERY ON BOTH IMPLANTS. THE SYMPTOMS WERE BENDING TOES AND PAIN IN THE LEGS STARTING IN THE CHEST. THE PATIENT WAS "OKAY" PRIOR TO THE INCIDENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention