BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2838448 · Received November 19, 2012

    Report

    Report Number
    3004209178-2012-10504
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    September 10, 2012
    Report Date
    October 31, 2012
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE STIMULATOR REVEALED NO ANOMALY FOUND. FINAL ANALYSIS OF THE ADAPTOR REVEALED NO ANOMALY FOUND. FINAL ANALYSIS OF THE ACCESSORY KIT REVEALED NO ANOMALY FOUND. FINAL ANALYSIS OF THE BOTH EXTENSIONS REVEALED NO SIGNIFICANT ANOMALIES FOUND. THE EXTENSION BODIES WERE CUT THROUGH AND THE PRODUCT WAS SEGMENTED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 7436 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 7428 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID, 64002 LOT# N283000, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ADAPTER PRODUCT ID, 3550-29 LOT#, PRODUCT TYPE ACCESSORY PRODUCT ID 3387S-40 LOT# V230715, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3387S-40 LOT# V227370, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE DEVICE WAS REPLACED BECAUSE, IT WAS NEAR "END OF SERVICE." AN ADAPTOR WAS USED DURING SURGERY, AND THIS ADDED DEVICE BULK IN THE IMPLANT SITE. A SMALLER / DIRECT CONNECT ALTERNATIVE WAS REQUESTED. NO PATIENT INJURY/ADVERSE EVENT WERE REPORTED WITH THIS SURGERY. ABOUT 7 WEEKS LATER, A "SHOCKING SENSATION" WHEN PATIENT MOVED HIS LEFT ARM OR PALPATED THE DEVICE IMPLANT SITE WAS REPORTED. NORMAL IMPEDANCES WERE REPORTED. AN X-RAY WAS PERFORMED, BUT IT "SHOWED NOTHING SIGNIFICANT." A REVISION SURGERY WAS PERFORMED ABOUT 3 WEEKS AFTER THESE TESTS. DURING THE SURGERY, IMPEDANCES OVER 40000 ON CONTACT 6 WERE REPORTED. IT WAS REPORTED, THE EXTENSIONS, THE POCKET ADAPTOR, AND THE NEUROSTIMULATOR WERE REPLACED. IMPEDANCES ON THE NEW IMPLANTS WERE REPORTED AS NORMAL, AND THE SHOCKING SENSATION WAS NOT ABLE TO BE REPLICATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention