BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3602493 · Received January 31, 2014

    Report

    Report Number
    3004209178-2014-01453
    Event Type
    Injury
    Date Received
    January 31, 2014
    Report Date
    January 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    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 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN; PRODUCT ID 3389S-40, LOT# V991333, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT# VA00WUZ, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPEDANCE FOR THE PATIENTS LEFT BRAIN IMPLANTABLE NEUROSTIMULATOR (INS) WERE AS FOLLOWS: (MEASUREMENT TAKEN AT 3.0V) C,0 5794 OHMS; C,1 NORMAL RANGE ~1400 OHMS; C,2 5371 OHMS; C,3 5495 OHMS; 0 ,1 4789 OHMS; 0,2 8030 OHMS; 0,3 7927 OHMS; 1,2 4450 OHMS; 1,3 4950 OHMS; 2,3 6499 OHMS. THE PATIENT WAS PROGRAMMED AT C+, 2- 60PW 130HZ 2.5V. IT WAS REPORTED THE PATIENT HAD MORE SYMPTOMS ON THE RIGHT SIDE OF HER BODY (LEFT BRAIN INS). IT WAS REPORTED SHE HAD SOME THERAPY BENEFIT, BUT NOT AS MUCH AS SHE WOULD LIKE. IT WAS NOTED SHE HAD BACK SURGERY A COUPLE OF MONTHS AGO, SO IT WAS DIFFICULT TO TELL WHAT WAS PARKINSON'S DISEASE SYMPTOMS AND WHAT WAS BACK SURGERY AFTER EFFECTS. IT WAS NOTED THE PATIENT'S PARKINSON'S SYMPTOMS WERE BETTER ON THE LEFT SIDE OF HER BODY (RIGHT BRAIN INS). IT WAS NOTED THE PATIENT FELL (UNKNOWN DATE) BUT SHE FELL ON HER KNEE AND DID NOT THINK THE INS/THERAPY WAS AFFECTED. ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTHCARE PROVIDER (HCP) DECIDED TO TEMPORARY TURN OFF THE DBS STIMULATION ON BOTH RIGHT AND LEFT SIDE INSS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SYSTEMS ON BOTH SIDES OF THE PATIENT WERE REMOVED. THE PATIENT REQUESTED THE REMOVAL DUE TO A LACK OF BENEFIT AND ANXIETY FROM THE DEVICE IN HER BODY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SURGEON PROVIDED VERY LITTLE DETAILS TO THE REPORTER. THERE WAS NO MALFUNCTION AND THE REPORTER WAS TOLD THE "PROTEST" DID RECEIVE BENEFIT FROM STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68096 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention