BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2319877 · Received November 2, 2011

    Report

    Report Number
    3004209178-2011-09026
    Event Type
    Malfunction
    Date Received
    November 2, 2011
    Date of Event
    September 10, 2011
    Report Date
    October 11, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEUROSTIMULATOR MODEL 37713 SERIAL# (B)(4) IMPLANTED: (B)(6) 2008 EXPLANTED: UNKNOWN; LEAD MODEL 3998 LOT# J0428353V IMPLANTED: (B)(6) 2004 EXPLANTED: UNKNOWN; LEAD MODEL 3998 LOT# V060415 IMPLANTED: (B)(6) 2008 EXPLANTED: UNKNOWN; EXTENSION MODEL 748951 SERIAL# (B)(4) IMPLANTED: (B)(6) 2004 EXPLANTED: UNKNOWN; EXTENSION MODEL 748951 SERIAL# (B)(4) IMPLANTED: (B)(6) 2004 EXPLANTED: UNKNOWN; EXTENSION MODEL 3708360 SERIAL# (B)(4) IMPLANTED: (B)(6) 2008 EXPLANTED: UNKNOWN; EXTENSION MODEL 3708360 SERIAL# (B)(4) IMPLANTED: (B)(6) 2008 EXPLANTED: UNKNOWN PROGRAMMER 37743 SERIAL# (B)(4); ACCESSORY MODEL 37752 SERIAL# (B)(4); PROGRAMMER MODEL 7435 SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT WHILE STIMULATION WAS TURNED ON. THE PATIENT COULD NO LONGER FEEL STIMULATION ON PROGRAM 2, WHICH THE PATIENT BELIEVED CORRELATED WITH HER LEFT SIDE. STIMULATION WAS FELT WITH PROGRAM 1. THE EVENT OCCURRED FOLLOWING "LUMBAR STRAIN" WHILE STRETCHING. THE PATIENT ALSO EXPERIENCED DISCOMFORT IN HER BACK WHERE THE LEADS WERE LOCATED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN IMPEDANCE OF OVER 20,000 OHMS WAS SEEN ON ELECTRODE 8. THE PATIENT WAS REPROGRAMMED AND RECEIVED COVERAGE IN BILATERAL UPPER BUTTOCKS TO ABOUT HER KNEES. THE PATIENT INDICATED THIS WAS MUCH BETTER THAN BEFORE. THE PATIENT PLANNED TO TRY THE NEW PROGRAMMING FOR 3 TO 4 WEEKS, BUT WAS STILL SORE FROM THE INJURY. THE PLAN WAS TO TAKE AN X-RAY IF THE PATIENT DID NOT GET RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR