BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 3023276 · Received March 27, 2013

    Report

    Report Number
    6000032-2013-00072
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 11, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3888-28, LOT# L59742, IMPLANTED: (B)(6) 1999, PRODUCT TYPE: LEAD. PRODUCT ID 7495-51, SERIAL# (B)(4)M IMPLANTED: (B)(6) 1999, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) "STOPPED WORKING IN 2009 DUE TO BATTERY DEPLETION". THE PATIENT REPORTED THAT THE INS "WAS HELPING WITH PAIN, EXCEPT [DURING] PERIODS WHERE NOTHING HELPED". THE PATIENT STATED THAT THEY WERE TOLD THAT "THE INS SHOULD HAVE LASTED LONGER" AND THAT "THERE MAY HAVE BEEN A SHORT IN IT THAT CAUSED IT TO STOP WORKING". IT WAS UNCLEAR AT THE TIME OF REPORT WHO TOLD THE PATIENT THIS. IT WAS NOTED THAT THE PATIENT'S HEALTH CARE PROVIDER (HCP) TOLD THE PATIENT THAT HIS "LEAD WAS PUT IN AT A DIAGONAL". IT WAS FURTHER NOTED THAT "DOCTORS TOLD THEM THERE WAS NO WAY THEY COULD HAVE CAUSED THE LEAD TO BE AT A DIAGONAL". THE PATIENT REPORTED HIS INS WAS EXPLANTED IN (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125104 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 Required Intervention