BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3132694 · Received May 29, 2013

    Report

    Report Number
    9614453-2013-01062
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    March 25, 2013
    Report Date
    May 7, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEATH CARE PROVIDER (HCP) WAS GOING TO MANAGE THE PATIENT WITH OTHER STIMULATION PARAMETERS. IT WAS STATED THAT THERE WILL BE NO INTERVENTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT IMPEDANCES WERE >4000 OHM ON CONTACT 10 (LEFT STN), OTHER CONTACTS WERE OK. IT WAS ALSO STATED THAT THE LEADS WERE NOT CONFIRMED TO BE THE CAUSE. TURNING THE STIMULATION OFF FOR MORE THAN 24 HOURS DID NOT RELIEVE THE DYSTONIA IN THE RIGHT HALF OF THE BODY. A RECENT CT SCAN WAS COMPARED TO A POST OPERATIVE CT, WHICH DID NOT REVEAL ANY GROSS DISLOCATION. CLINICALLY, THE LOWEST CONTACTS INCREASED BRADYKINESIA, YET REDUCED RIGIDITY SUGGESTING THAT THE LOWEST CONTACTS DO STIMULATE THE NIGRA. WHEN THE PATIENT LEFT THE HOSPITAL 16 DAYS AGO, HE DID QUITE WELL. THE PATIENT HAD 80% ON TIME OFF WHICH WAS 25% ON WITH MILD DYSKINESIA. A WEEK PRIOR TO THE REPORT, THE PATIENT REPORTED 70% OFF. THE FREQUENCY WAS INCREASED TO 130 HZ WHICH RESULTED IN IMMEDIATE IMPROVEMENT IN RIGIDITY AND BRADYKINESIA WITHOUT ANY EFFECT ON THE DYSTONIA. DOPAMINE MEDICATION WAS INCREASED. IN TURNING OFF STIMULATION AND ¿MED OFF¿, THE PATIENT¿S CONDITION WAS SIMILAR TO PREOPERATIVE ¿MED OFF¿ CONDITION, BUT ADDITIONAL DYSTONIA OF THE RIGHT SIDE OF THE BODY. HAVING STIMULATION OFF BUT ¿MED ON¿, RESULTED IN CLINICALLY SIMILAR TO THE PREOPERATIVE ¿MED ON¿ CONDITION, BUT DYSTONIA WAS UNCHANGED. ADDING AMANTADINE HAD NO EFFECT ON THE DYSTONIA. UTILIZING THE MOST EFFICACIOUS CONTACTS HAD NO EFFECT ON THE DYSTONIA; NEITHER DID BIPOLAR STIMULATION. LOW FREQUENCY MONOPOLAR STIMULATION (60 HZ) SEEMED PROMISING AT FIRST OVER A WEEK, BUT EFFICACY WANED. NO EFFECT ON DYSTONIA SO THE PATIENT RESUMED THE REGULAR RATE OF 130 HZ. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE WEEK AFTER THE STIMULATOR WAS IMPLANTED, THE PATIENT HAD DYSTONIA IN HIS RIGHT ARM. THERE WERE HIGH IMPEDANCES. THE PHYSICIAN SPECULATED THAT THE LEADS WERE TOO DEEP. THE PATIENT WAS NOTED TO BE ALIVE WITH NO INJURY/ADVERSE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235566 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1