BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2933700 · Received January 29, 2013

    Report

    Report Number
    3007566237-2013-00309
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID 3550S-01, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN IMPLANT PROCEDURE, THE HEALTH CARE PROVIDER (HCP) REPORTED LEAD MIGRATION. IT WAS STATED THAT THE HCP LOCKED THE LEAD IN PLACE WITH LOCKING CAP, THEN APPLIED "TRACTION" TO THE LEAD, WHICH THEN "MOVED UP". THE MOVEMENT WAS CONFIRMED BY FLUOROSCOPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    FOLLOW UP REPORTED FLUOROSCOPY WAS USED IN THE CASE TO ASSESS THE PLACEMENT OF THE LEAD AFTER INSERTION, AFTER STIMLOC WAS SECURED AND AFTER ALL EQUIPMENT WAS REMOVED FROM THE FRAME. SURGEON MANUALLY PULLED ON LEAD AFTER STIMLOC WAS 'SECURED' AND FLUOROSCOPY SHOWED THAT THE LEAD HAD RETRACTED. THE HCP PUSHED THE LEAD BACK TO TARGET AND CLOSED. IT WAS NOTED THERE WERE NO INTERVENTIONS TAKEN OR PLANNED. THE PATIENT RECOVERED WITHOUT PROBLEMS. PATIENT WAS AWAITING A STAGE TWO STIMULATOR IMPLANT. 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. REFER TO MANUFACTURER REPORT # 3007566237-2013-00366. REPORT ON PATIENT WITH SIMILAR EVENT WITH THE SAME HEALTH CARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39248 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR