BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7437966 · Received April 17, 2018

    Report

    Report Number
    3004209178-2018-08242
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    February 8, 2018
    Report Date
    May 1, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761057
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP INDICATING THAT THE CAUSE OF THE HIGH IMPEDANCES WAS NOT DETERMINED AND THE ISSUE IS NOT YET RESOLVED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT IS HAVING MOUTH AND HAND TREMOR MORE THAN USUAL SINCE HIS MOST RECENT REPLACEMENT SURGERY. HE FEELS A SLIGHT LACK OF COORDINATION, AND IT'S WORSE AT NIGHT THAN IT IS DURING THE DAY. UNKNOWN IF ANY ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS MAY HAVE LED TO THE ISSUE. DIAGNOSTICS/TROUBLESHOOTING INCLUDED CHECKING THE BATTERIES OVER THE PHONE AND THEY ARE ON, WORKING NORMALLY. INTERVENTIONS/ACTIONS INCLUDED RECOMMENDING THE PATIENT SEE A LOCAL NEUROLOGIST. THE ISSUE IS NOT RESOLVED AND THE PATIENT WILL FOLLOW-UP WITH THE REP. NO SURGICAL INTERVENTION OCCURRED AND NONE IS PLANNED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. IT WAS REPORTED THE PATIENT NEEDED TO SEE A NEUROLOGIST FIRST BEFORE MORE INFORMATION WOULD BE AVAILABLE. THE PATIENT DIDN'T HAVE THE ABILITY TO MAKE STIMULATION CHANGES USING THEIR REMOTE OTHER THAN CHANGING GROUPS. THE REP DID NOT RECOMMEND THEY CHANGE GROUPS WITHOUT THE CONSENT AND DIRECTION OF A PHYSICIAN. THE CAUSE OF THE TREMORS AND LACK OF COORDINATION WAS UNKNOWN. THE ISSUE REMAINED UNRESOLVED. ADDITIONAL INFORMATION WAS RECEIVED. ELECTRODE IMPEDANCES: C 445, 803 C 559, 696 C, 564, C 368, 758, 673, 661. GROUP A: UPPER 3.2 60 PROGRAMMED 3.2 60 LOWER 3.2 60 RESOLUTION 0.1 NA. GROUP B: UPPER 3.4 60 PROGRAMMED 3.4 60 LOWER 3.4 60 RESOLUTION 0.1 NA ADDITIONAL INFORMATION WAS RECEIVED. C 2490, 2698 C, 698, 2895 C, 684, 810 C, 742, 985 0, 2233, 792. ADDITIONAL INFORMATION WAS RECEIVED. C 2490, 2698 C, 698, 2895 C, 684, 810 C, 742, 985, 2233, 792. ADDITIONAL INFORMATION WAS RECEIVED. THEY MET WITH THE PATIENT AND CONFIRMED THE SYMPTOMS. CHECKED BOTH LEFT AND RIGHT INS. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278874 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602 00613994761057

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR