BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2950392 · Received February 8, 2013

    Report

    Report Number
    3004209178-2013-01480
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 30, 2013
    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

    PRODUCT ID 3998, LOT# J0417753V, IMPLANTED: 2004-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: EXTENSION: PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: EXTENSION: PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3998, LOT# J0417753V, IMPLANTED: (B)(6) 2004. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS ATTRIBUTED TO THE INS AND LEAD WHERE IT CONFIRMED THAT ALL IMPEDANCE MEASUREMENTS WERE >3600 OHMS. THE ENTIRE INS SYSTEM WAS THEN REPLACED. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FEELING STIMULATION THE WEEK PRIOR TO THE REPORT, BUT IT JUST STOPPED. THERE WERE NO REPORTED FALLS OR TRAUMAS. WHEN THE DEVICE WAS INTERROGATED BY THE CLINICIAN PROGRAMMER THERE WAS NO POWER ON RESET (POR) MESSAGE AND THE PATIENT WAS STILL PROGRAMMED TO HIS CURRENT SETTINGS. THE PATIENT'S BATTERY VOLTAGE WAS 2.56 VOLTS, BUT THE DEVICE HAD BEEN OFF FOR A "WEEK OR SO." AN IMPEDANCE TEST SHOWED THAT "ALMOST ALL" OF THE ELECTRODE PAIRS WERE GREATER THAN 4,000 OHMS OR OPEN. THE ONLY VIABLE PAIRS APPEARED TO BE 2 AND 4, 2 AND 7, AND 4 AND 7. LATER THAT DAY IT WAS REPORTED THAT REPROGRAMMING AROUND THE OPENS WAS UNSUCCESSFUL. ADDITIONAL INFORMATION RECEIVED FOUR DAYS LATER REPORTED THAT NO CAUSE OF THE ISSUE WAS DETERMINED. THE PATIENT WAS SCHEDULED TO SEE HIS HEALTH CARE PROVIDER (HCP) FOR A POSSIBLE REVISION. THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55120 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention