BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2850240 · Received November 29, 2012

    Report

    Report Number
    3004209178-2012-10900
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    October 30, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, NEU_SILICONE ANCHOR, PRODUCT TYPE ACCESSORY PRODUCT ID, NEU_SILICONE ANCHOR, PRODUCT TYPE ACCESSORY PRODUCT ID, 748925 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 748925 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 7435 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 389033 LOT# J0504249V, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 389033 LOT# J0412301V, IMPLANTED: 2005 (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.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO SIGNIFICANT ANOMALY. IT WAS STATED THE INS BATTERY WAS AT NORMAL END OF LIFE AND TELEMETRY AND OUTPUT WERE OKAY. IT WAS NOTED THE OUTPUT WAS GOOD ON ALL ELECTRODE COMBINATIONS FROM THE INS TO THE CUT END OF THE EXTENSIONS. ANALYSIS OF THE EXTENSION (S/N: (B)(4)) FOUND NO SIGNIFICANT ANOMALY. IT WAS STATED THE BODY OF THE EXTENSION WAS CUT THROUGH AND THE PRODUCT WAS SEGMENTED. IT WAS NOTED THAT CONTINUITY WAS ACCEPTABLE AND THERE WERE "NO SHORTS - DRY" ANALYSIS OF THE EXTENSION (S/N: (B)(4)) FOUND NO SIGNIFICANT ANOMALY. IT WAS STATED THE BODY OF THE EXTENSION WAS CUT THROUGH AND THE PRODUCT WAS SEGMENTED. IT WAS NOTED THAT CONTINUITY WAS ACCEPTABLE AND THERE WERE "NO SHORTS - DRY" ANALYSIS OF THE LEAD (LOT # J0504249V) FOUND NO SIGNIFICANT ANOMALY. IT WAS STATED THE BODY OF THE LEAD WAS CUT THROUGH AND THE PRODUCT WAS SEGMENTED. IT WAS NOTED THAT CONTINUITY WAS ACCEPTABLE AND THERE WERE "NO SHORTS - DRY" ANALYSIS OF THE LEAD (LOT # J0412301V) FOUND THE BODY OF THE CONDUCTOR TO BE BROKEN AT THE SILICONE ANCHOR SITE. IT WAS STATED THAT CIRCUITS 0, 2, AND 3 WERE OPEN. CONTINUITY WAS ACCEPTABLE ON CIRCUIT 1. IT WAS NOTED CONDUCTOR WIRES 0, 2, AND 3 WERE BROKEN 15 CM FROM THE DISTAL END AT THE THREE WING ANCHOR SITE, 16 CM FROM THE DISTAL END. ANALYSIS OF ANCHOR 1 FOUND NO ANOMALY. ANALYSIS OF ANCHOR 2 FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS EXPLANTED AND REPLACED. THE BATTERY DEPLETED NORMALLY, BUT THERE WAS A DECREASE IN STIMULATION AND "HIGH" IMPEDANCES WERE REPORTED. THE PATIENT HAD DECREASED STIMULATION TO HER LOW BACK AND WITH THE "HIGH" IMPEDANCES SHE HAD TO INCREASE THE INTENSITY UNTIL SHE HAD NO LOW BACK COVERAGE. THERE WAS NO PATIENT INJURY AND SHE RECOVERED WITHOUT SEQUELA.

    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 00043 YR Required Intervention