BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 8951354 · Received August 30, 2019

    Report

    Report Number
    3004209178-2019-16711
    Event Type
    Injury
    Date Received
    August 30, 2019
    Date of Event
    August 1, 2007
    Report Date
    August 30, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    UDI-DI
    00613994934604
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V023550, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID: 3387S-40, LOT# V026844, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 07-DEC-2009, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ON 2019-JUN-21 (B)(4) (CON): INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. THE RIGHT AND LEFT "PROBE PLACEMENT" WAS IN (B)(6) 2007 WITH A DUAL PORT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER. FOLLOWING ATTEMPTS TO OBTAIN GOOD PROGRAMMING RESULTS FROM TWO NEUROLOGISTS WITH NO SUCCESS. THE SECOND NEUROLOGIST REALIZED SOMETHING WAS NOT RIGHT, AND REFERRED THE PATIENT TO A DIFFERENT HEALTH CARE PROVIDER (HCP) FOR TROUBLESHOOTING. IT WAS REPORTED THAT THE PATIENT WAS SEEN IN (B)(6) 2010 FOR DBS TROUBLESHOOTING. BASED ON THE FINDINGS FROM TROUBLESHOOTING, IT WAS SUSPECTED AND CONFIRMED WITH MRI THAT BOTH LEADS WERE MALPOSITIONED. IT WAS "PRETTY WELL DETERMINED" THERE WAS NO MALFUNCTION OF THE NEUROSTIMULATOR AS THEY WORKED QUITE WELL. THE LEFT LEAD WAS PLACED TOO LATERAL AND POSTERIOR, SO THE NEUROSURGEON PLACED IT ABOUT 2 MM MORE MEDIAL AND 3 MM MORE ANTERIOR, WHICH PRODUCED, BASED ON WRITING SAMPLES, VIRTUALLY COMPLETE TREMOR CONTROL AT 3 VOLTS WITHOUT ANY SIDE EFFECTS. ON (B)(6) 2010, THE LEFT LEAD WAS REVISED WITH NO SURGICAL COMPLICATIONS, GOOD HEALING, NO HEAD OR VOICE OR DISABLING BILATERAL HAND TREMOR. IMPEDANCES WERE NORMAL AFTER REVISION, AND THE PATIENT AND PHYSICIAN WERE PLEASED WITH THE OUTCOME OF THE LEFT LEAD RE VISION. THE RIGHT LEAD WAS ALSO DETERMINED TO BE PLACED PRETTY LATERAL AND POSTERIOR; HOWEVER, AT THE TIME OF THE LEFT LEAD REVISION, THE PHYSICIAN DECIDED TO LET THE PATIENT DECIDE IF THE RIGHT LEAD WOULD BE REVISED AFTER PROGRAMMING HOW GOOD THE LASTING EFFECT WAS ON THE RIGHT SIDE. IT WAS NOTED THE PATIENT HAD LESS THAN ADEQUATE TREMOR CONTROL ON THE LEFT SIDE (RIGHT LEAD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743263 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601 00613994934604

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention