BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2594774 · Received May 31, 2012

    Report

    Report Number
    3004209178-2012-03881
    Event Type
    Injury
    Date Received
    May 31, 2012
    Report Date
    May 3, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    ADAPTOR ACCESSORY: MODEL 748966, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: NA. ADAPTOR ACCESSORY: MODEL 748966, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: NA. PROGRAMMER: MODEL 7435, SERIAL# (B)(4). LEAD: MODEL 3986A, LOT# N182431, IMPLANTED: (B)(6) 2009, EXPLANTED: NA. LEAD: MODEL 3986A, LOT# N179496, IMPLANTED: (B)(6) 2009, EXPLANTED: NA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET SITE AND A LOSS OF THERAPEUTIC EFFECT FOLLOWING A FALL IN WHICH SHE FELL BACK AND HIT HER HEAD. IMPEDANCES MEASUREMENTS SHOWED SOME OF THE BIPOLAR ELECTRODE PAIRS WERE DOUBLE OTHER BIPOLAR COMBINATIONS (AT <(><<)>15 UA). IMPEDANCE PROBLEMS WERE NOTED ON BOTH LEADS. THE PATIENT FELT LIKE HER LEADS WERE NOT WORKING. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS GOING TO HAVE THE ENTIRE SYSTEM REPLACED. THE DATE OF REPLACEMENT WAS NOT KNOWN. ALL IMPEDANCES WERE OUT OF RANGE. THE PATIENT WAS SUSPECTED OF HAVING AN UNRELATED INFECTION AND WAS ON ANTIBIOTICS. DUE TO INFECTION, THE PHYSICIAN WANTED TO WAIT AT LEAST 6 MONTHS UNTIL REPLACEMENT.

    Description of Event or Problem · 1

    PREVIOUSLY REPORTED INFORMATION INDICATED THE PATIENT HAD FALLEN AND THE IMPEDANCES WERE OUT OF RANGE. NEW INFORMATION REPORTED THE PATIENT'S LEADS WERE REPLACED BECAUSE THEY HAD BROKEN AS A RESULT OF THE FALL. SINCE THE LEAD REPLACEMENT THE PATIENT HAS LOST ALOT OF COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention