BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 9541113 · Received January 2, 2020

    Report

    Report Number
    1030489-2020-00012
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 11, 2019
    Report Date
    January 23, 2020
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    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

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR OTHER CHRONIC/INTRACT PAIN (TRUNK/LIMBS). INFORMATION WAS REPORTED THAT THE REP WANTED ASSISTANCE TO CHECK AND INTERPRET THE PATIENT'S IMPEDANCES RESULTS: 01 1744 02 862 03 1161 04 990 05 1161 06 1161 07 3541 12 1400 13 ? 14 ? 15 2354 16 2354 17 3541 23 862 24 990 25 990 26 1161 27 3541 34 1161 35 ? 36 1161 37 3541 4 VOLTS 450PW IMPEDANCE TEST 07 4000 17 4000 37 4000 IT WAS REVIEWED THAT ELECTRODE 7 APPEARS TO HAVE A POSSIBLE OPEN CIRCUIT, THE OTHER IMPEDANCE RESULTS LOOK FINE. THE PATIENT IS NEEDING A NEW INS. THEIR CURRENT PROGRAM 1+2-3+ 330PW 30HZ, 5 VOLTS, LOOKS LIKE IT WOULD ACCOMMODATE TO PATIENT'S NEEDS SINCE ELECTRODE 7 ISN'T NEEDED. NO FURTHER COMPLICATIONS WERE REPORTED. NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) 2019-12-16. IT WAS REPORTED THAT THE CAUSE OF THE IMPEDANCE ISSUE WAS UNKNOWN. IT WAS NOT IN THE AREA OF PROGRAMMING. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    REP REPORTED THAT PATIENT'S WEIGHT WAS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR