BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY VERSITREL

    MDR report key: 2954982 · Received February 11, 2013

    Report

    Report Number
    6000032-2013-00037
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7498-66,SERIAL# (B)(4), IMPLANTED: (B)(6) 1997, PRODUCT TYPE: EXTENSION. PRODUCT ID 7435, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3888-28, LOT# L47827, IMPLANTED: (B)(6) 1997, PRODUCT TYPE: LEAD. PRODUCT ID 3888-28, LOT# L47827, IMPLANTED: (B)(6) 1997, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE BATTERY WAS REPLACED AND THE PATIENT WAS DOING GREAT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN STIMULATION WAS TURNED ON, THERE WAS A JERKING SENSATION IN THE PATIENT'S ARMS WHICH WAS "OFF AND ON" AND NOT CONSTANT. THE REPORTER STATED THAT THE PATIENT HAD THE DEVICE FOR PAIN IN THE ARMS AND HANDS AND TYPICALLY STIMULATION WAS FELT IN THAT LOCATION. IT WAS NOTED THAT WHEN STIMULATION WAS NOT CAUSING JERKING IT WAS COMFORTABLE FOR THE PATIENT. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE COMPLAINT. IT WAS REPORTED THAT THE SENSATION STARTED A COUPLE OF MONTHS AGO. IT WAS NOTED THAT THE PATIENT WAS IN A CAR ACCIDENT A YEAR AGO BUT DID NOT CORRELATE THE JERKING SENSATION STARTING WITH THE ACCIDENT. THE REPORTER STATED THAT THERE WERE IMPEDANCES GREATER THAN 4000 OHMS ON ELECTRODE PAIR COMBINATIONS WITH ELECTRODES 4, 5, 6, AND 7. OTHER PAIRS WERE IN THE RANGE OF 456-617 OHMS. IT WAS REPORTED THAT THE LEADS WERE PLACED IN THE CERVICAL AREA. IT WAS NOTED THAT THE DEVICE BATTERY VOLTAGE WAS 2.56 VOLTS AND HAD BEEN ON SINCE 6 A.M. THE MORNING OF THE REPORT. IT WAS REPORTED THAT THE PATIENT TYPICALLY USED STIMULATION ONLY WHEN SHE WAS AWAKE. SIX DAYS LATER, IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR BATTERY WAS LOW OR AT END-OF-LIFE AND NEEDED TO BE REPLACED. THE REPORTER STATED THAT THERE WERE NO BATTERY CONCERNS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58932 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1