BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4124022 · Received September 27, 2014

    Report

    Report Number
    3004209178-2014-17850
    Event Type
    Injury
    Date Received
    September 27, 2014
    Report Date
    September 4, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 3387-40, LOT# J0437135V, IMPLANTED: 2004-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED (B)(6)-2014, AND THEY ALSO REPLACED SOME OF THE WIRING BECAUSE IT WAS SHORTED OUT ¿OR SOMETHING¿ FROM THE EAR DOWN. NO OUTCOME WAS REPORTED FOR THIS EVENT AND ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603652 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Required Intervention