BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2946326 · Received February 6, 2013

    Report

    Report Number
    3007566237-2013-00389
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 18, 2013
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_STIMLOC_ACC, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3389S-40, LOT# VA03YKJ, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# VA01PN5, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. THE INITIAL MDR WAS FILED AS MFR REPORT # 3007566237-2013-00389. ADDITIONAL REVIEW INDICATED THE CORRECT MANUFACTURING SITE WAS. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE STIMLOC ACCESSORY LOT UNKNOWN FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD PRODUCT ID NEU_STIMLOC_ACC, SERIAL# UNKNOWN, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD TO HAVE HIS LEAD REPOSITIONED AS IT HAD PULLED APPROXIMATELY 1 CM OUT OF THE STN AND WAS 1 CM SUPERFICIAL TO THE TARGET. THE PATIENT WAS DOING FINE FOLLOWING THE REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS LEAD MIGRATION AND THE LEAD LOCKING MECHANISM HAD OPENED. AN MRI SHOWED THE LEAD HAD PULLED OUT "ABOUT ONE CENTIMETER." THE LEAD LOCKING MECHANISM WAS EXPLANTED AND RETURNED TO THE MANUFACTURER TO BE EXAMINED. THE PATIENT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50148 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention