BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3051818 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05979
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    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: 748910 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 7435 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 748910 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3093-28 LOT# V172100, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3093-28 LOT# V168016, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION WHEN THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED ON. IT WAS FURTHER REPORTED THAT THE PATIENT HAD THEIR INS TURNED OFF AT THE TIME OF REPORT. FOUR DAYS LATER IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE MET THE PATIENT ALONG WITH THE HEALTH CARE PROVIDER (HCP). IT WAS STATED THAT THE PATIENT HAD BEEN IMPLANTED "OFF LABEL". A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149350 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1