BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2655494 · Received July 14, 2012

    Report

    Report Number
    3004209178-2012-05615
    Event Type
    Injury
    Date Received
    July 14, 2012
    Report Date
    June 18, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37642 LOT#, SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYP PROGRAMMER, PATIENT; PRODUCT ID 37085-40, LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: PRODUCT TYP EXTENSION; PRODUCT ID 37085-40, LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: PRODUCT TYP EXTENSION; PRODUCT ID 3387S-40, LOT# V011938 SERIAL# IMPLANTED: 2007 (B)(6), EXPLANTED: PRODUCT TYP LEAD; PRODUCT ID 3387S-40, LOT# V014246 SERIAL# IMPLANTED: 2007 (B)(6), EXPLANTED: PRODUCT TYP LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TWO SHORTED LEADS AND THEREFORE, THE PATIENT'S BATTERY BECAME DEPLETED. THE IMPLANTABLE NEUROSTIMULATOR WAS REPLACED. IT WAS UNCLEAR IF THE LEADS WERE REPLACED AS WELL. POST-SURGERY, THE PATIENT HAD GREAT TREMOR CONTROL AND WAS HAPPY WITH THE RESULTS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATES THE INFORMATION IN MFR REPORT # 3004209178-2012-05663 PERTAINS TO THIS MANUFACTURER'S REPORT. ANY ADDITIONAL INFO WILL BE REPORTED IN THIS REPORT.

    Description of Event or Problem · 1

    FOLLOWING ADDITIONAL REVIEW MANUFACTURER REPORT#3004209178-2012-05663 WILL REMAIN SEPARATE FROM 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 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention