BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2881618 · Received December 20, 2012

    Report

    Report Number
    3007566237-2012-03071
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    August 2, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37085-60, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3387, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LEAD EXPLANTED AND REPLACED. THE PATIENT WAS REPORTEDLY PROGRAMMED POST-OPERATIVELY FOR 5 CONSECUTIVE DAYS WITH GOOD CLINICAL BENEFIT. IT WAS THEN REPORTED THAT THE PATIENT WAS "TRANSFERRED UP THE BED" BY NURSING STAFF AND FELT A PAIN ON THE LEFT SIDE OF HIS NECK. FOLLOWING THIS INCIDENT THE PATIENT'S RIGHT HAND TREMOR RETURNED. AN X-RAY WAS REPORTEDLY TAKEN AND REVEALED THAT THE LEAD AND EXTENSION CONNECTION POSSIBLY DID NOT LINE UP. VOLTAGE TO THE LEFT STN WAS SUBSEQUENTLY REDUCED TO 0 VOLTS AND IMPEDANCE MEASUREMENTS DID NOT INDICATE ANY OUT OF RANGE RESULTS. IT WAS FURTHER REPORTED THAT SURGERY WAS PERFORMED ON (B)(6) 2012 TO INVESTIGATE THE CONNECTION AND TEST THE LEAD INTER-OPERATIVELY. TESTING REPORTEDLY REVEALED THAT THE PATIENT WAS GETTING NO CLINICAL BENEFIT OR REPRODUCTION OF SIDE EFFECTS AT 10.5 VOLTS. THE LEAD WAS REPORTEDLY REPLACED DURING A FURTHER SURGERY DONE ON (B)(6) 2012. IT WAS NOTED THAT THE REASON FOR REMOVAL WAS A LEAD BREAKAGE. IT WAS FURTHER NOTED THAT THERE WAS NO PATIENT DEATH AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention