BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4764867 · Received May 12, 2015

    Report

    Report Number
    3004209178-2015-08907
    Event Type
    Injury
    Date Received
    May 12, 2015
    Report Date
    April 23, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    PRODUCT ID 64001, LOT# N460485, IMPLANTED: 2014 (B)(6); PRODUCT TYPE ADAPTER PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37651, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 3387S-40, LOT# V821660, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A STIMULATION/THERAPY ISSUE; THE PATIENT HAD A FEELING OF ELECTRICAL CURRENT IN HIS BODY DURING THE RECHARGING PROCESS. THE PATIENT ALSO HAD TREMOR RETURNING IN HIS HANDS. THE PATIENT HAD HAD THE DEVICE CHECKED BY AN UNKNOWN PHYSICIAN BUT THE PROBLEM HAD PERSISTED. A SURGICAL INTERVENTION WAS PLANNED, THE PATIENT WAS GOING TO UNDERGO SURGERY ON (B)(6) 2015 TO DIAGNOSE THE ISSUE AND POSSIBLY REPLACE EQUIPMENT. NO OUTCOME WAS REPORTED, FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309643 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention