BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3325493 · Received September 4, 2013

    Report

    Report Number
    3004209178-2013-15651
    Event Type
    Injury
    Date Received
    September 4, 2013
    Report Date
    August 9, 2013
    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

    PRODUCT ID 3387S-40 LOT# V020086, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7426 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 7438 LOT# SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387-40 LOT# J0337627V, IMPLANTED: 2004 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7426 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED REGARDING THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED SHOCKING SENSATIONS AT THE RIGHT INS FOR THE PAST TWO WEEKS. WHEN HE PRESSED ON THE RIGHT INS HE FELT UNCOMFORTABLE. HE DENIED ANY FALLS OR TRAUMA IN THE LAST COUPLE OF WEEKS. HE DID FALL ONE MONTH AGO WHILE PLAYING GOLF. HIS NORMAL FALL WAS ROLLING. THERE WAS NO SHOCKING WHEN THE STIMULATION WAS ON BUT WITH PALPITATION AT THE HEADER BLOCK HE DID FEEL A SHOCKING SENSATION. THE IMPEDANCE MEASUREMENTS WERE: C0 3318 OHMS C1 908 OHMS C2 860 OHMS C3 770 OHMS 01 4015 OHMS 02 4335 OHMS 03 4287 OHMS 12 988 OHMS 13 1159 OHMS 23 918 OHMS. THE DEVICE WAS PROGRAMMED AT 0+1-2-3+ 2.8V/180/130HZ. THERAPY IMPEDANCE WAS 698OHMS, 3.979MA WITH INS BATTERY VOLTAGE 2.92V. THE THERAPY WAS DOING GREAT WITH CONTROLLING HIS SYMPTOMS. A REVISION SURGERY WAS NEEDED TO ADDRESS THE SHOCKING AT THE HEADER BLOCK OF THE RIGHT SIDED INS. THE LEFT SIDED INS LONGEVITY CALCULATION INDICATED 40 MONTHS. THE LEFT SIDED INS WAS BEING CONSIDERED TO GET CHANGED OUT DURING SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437218 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention