BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 9124702 · Received September 26, 2019

    Report

    Report Number
    3004209178-2019-18492
    Event Type
    Injury
    Date Received
    September 26, 2019
    Date of Event
    June 1, 2019
    Report Date
    October 18, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000175719
    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

    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

    INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON¿S DUAL, MOVEMENT DISORDERS. IT WAS REPORTED THAT THE CALLER SAID THE PATIENT WAS FEELING A CONSTANT 9V BATTERY FEELING BEHIND THEIR EAR. IT GOT BETTER AND THEN CAME BACK SINCE THEIR OOR ISSUE STARTED. THE PATIENT INDICATED THAT WHEN TURNING THEIR HEAD TO THE LEFT IT WAS WORSE. THE PATIENT FIRST GOT THE OOR MESSAGE ON THE PATIENT CONTROLLER OVER THE WEEKEND OF (B)(6) 2019. THE CALLER STATED THAT THEY WERE GETTING THE OOR ON THE PATIENT¿S CONTROLLER AND ON THE CLINICIAN TABLET. THE CALLER STATED THAT PRIOR TO THE CALLER THEY DECREASED THE PARAMETERS FROM 4 TO 3.8V AND THE OOR WENT AWAY, THEN THEY INCREASED IT AGAIN AND THE OOR DIDN¿T COME BACK. THE PATIENT WAS SET UP ON INTERLEAVING PARAMETERS WITH THE FOLLOWING SETTINGS: P1 -0 +3 3.8V 120US 125HZ P1 -0 +3 3.8V 90US 125HZ THE CALLER PROVIDED THE FOLLOWING IMPEDANCES FROM THE TABLET SESSION TODAY: 10 2500, 20 1700, 21 1900, 30 2000, 31 2000, 32 1200 TECHNICAL SERVICES HAD THE CALLER ATTEMPT TO INCREASE THE AMPLITUDE WITH THE CLINICIAN TABLET AND THE OOR MESSAGE OCCURRED AGAIN. THIS TIME THE INS WAS IN OOR AT 3.8V. TECHNICAL SERVICES HAD THE CALLER DECREASE TO 3.7V AND IT CAME OUT OF THE OOR, THEN INCREASED TO 3.8V AND THE OOR DIDN¿T RECUR. THE REP ENDED THE SESSION, RE-INTERROGATED WITH THE CLINICIAN PROGRAMMER AND THE OOR MESSAGE DIDN¿T COME BACK, THE PATIENT WAS STILL AT 3.8V. THE REP INCREASED THE AMPLITUDE TO 4V ON BOTH PROGRAMS AND THE DEVICE WAS NOT IN OOR. THE CALLER STATED THAT THE PATIENT DIDN¿T MAKE REGULAR ADJUSTMENTS WITH THEIR PROGRAMMER, THE LAST TIME THEY DID WAS 2 MONTHS AGO. CURRENT BATTERY VOLTAGE WAS AT 2.9V, AND THE PATIENT¿S TREMOR CONTROL WAS GOOD. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE CAUSE OF THE 9V BATTERY FEELING BEHIND THEIR EAR WAS UNKNOWN. THE PATIENT WAS SCHEDULED FOR AN IMPLANT OF THE OTHER SIDE SOON AND THE SURGEON PLANNED ON DISCONNECTING AND RESEATING THAT CONNECTION TO SEE IF IT HELPED. THE OOR WAS RESOLVED OVER THE PHONE. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919674 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00763000175719

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention