BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1359713 · Received March 4, 2009

    Report

    Report Number
    3004209178-2009-01512
    Event Type
    Malfunction
    Date Received
    March 4, 2009
    Date of Event
    January 1, 2009
    Report Date
    February 3, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD READINGS >4000 OHMS ON 0-3 PAIR AT 1.5V. VOLTAGE WAS INCREASED TO 4V AND RE-RUN. THE RESULTS WERE 0-1 WAS 1250 OHMS 19MA, 02 1883 OHMS 15NA, 0-3 3762 OHMS <15MA, 1-2 1250 OHMS 19MA, 1-3 1883 OHMS <15MA, AND 2-3 1883 OHMS <15MA. THERAPY IMPEDANCE OF 1-, 3+ WAS 296 OHMS, 32MA RUNNING AT 10.5V 450PW, 50 HZ. THE PATIENT WAS NOT FEELING STIMULATION WITH ANY OF THE COMBINATIONS. A REVISION WAS DONE TO REPLACE THE NEUROSTIMULATOR, AS IT WAS NEAR LOW BATTERY (2.48V). THE PHYSICIAN WAS NOT PLANNING GOING TO DO A LEAD REVISION. NO PATIENT OUTCOME WAS REPORTED. REFERENCE MFR REPORT #2182207200901402 FOR ISSUES FOLLOWING STIMULATOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR EXPLANTED:| LEAD: MODEL 3550-09| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3587A| EXTENSION: MODEL 7495LZ| EXPLANTED: