BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 7956940 · Received October 11, 2018

    Report

    Report Number
    3004209178-2018-22826
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Report Date
    October 11, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3998, LOT#: J0427775V, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3998, SERIAL/LOT #: (B)(4), UBD: 25-MAY-2008, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE MANUFACTURER'S REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL CORD STIMULATION - NON-MALIGNANT PAIN/FAILED BACK SURGERY SYNDROME. IT WAS REPORTED THAT IMPEDANCE VALUES HAD DECREASED SINCE THE INITIAL MEETING. THE MANUFACTURER'S REPRESENTATIVE (REP) STATED THAT 2 CONTACTS ON SPECIFY LEAD WERE BAD PREVIOUS TO NEW NEUROSTIMULATOR (INS) BEING PLACED. THE SAME PROGRAMMING WAS USED FROM THE OLD INS FOR NEW INS AND BOTH PROGRAMS 1 AND 2 WERE USING A BAD LEAD. REP MENTIONED PATIENT HAD SHORTS PRIOR TO SURGERY BUT DID NOT HAVE ANY SPECIFIC INFORMATION. IMPEDANCES WERE TESTED AND THE FOLLOWING IMPEDANCES RESULTS WERE AS REPORTED: INITIAL IMPEDANCE DAY OF IMPLANT: 240-920 OHMS IMPEDANCE RESULTS TODAY, (B)(6) 2018: 240-470 WITH REPORT SHOWING POSSIBLE SHORT ON CONTACTS 0, 2, 4, 5, 6. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP WHO REPORTED THEY WERE MADE AWARE ON THE SAME DAY THEY REPORTED THIS EVENT, ON (B)(6). IT WAS REPORTED THE REP REPROGRAMMED THE CONTACTS. CAUSE WAS NOT DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797557 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1