BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 3113787 · Received May 15, 2013

    Report

    Report Number
    9614453-2013-01052
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3887-33, LOT# V165217, IMPLANTED: 2008-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3887-33, LOT# V174728, IMPLANTED: 2008-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD, MODEL #3887-33, FOUND THE 2 CONDUCTORS OF THE LEAD WIRE TO BE BROKEN AT 12.1 CM AND 15 CM FROM THE DISTAL END. NO SHORT CIRCUITS WERE FOUND. ANALYSIS OF THE LEAD, MODEL #3887-33, FOUND ALL FOUR CONDUCTORS OF THE LEAD WIRE TO BE BROKEN 12 CM FROM THE DISTAL END. IT WAS NOTED THAT THE BODY INSULATION WAS CUT, THE LEAD WAS SEGMENTED. NO SHORT CIRCUITS WERE FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION. IT WAS STATED THAT IMPEDANCES WERE CHECKED AND SHOWED OVER 2000 OHMS. A LEAD FRACTURE WAS REPORTEDLY CONFIRMED AND REVISION WAS SCHEDULED. IT WAS REPORTED A MONTH LATER THAT NEW LEADS WERE IMPLANTED. IT WAS STATED THAT THE "JACKET TUBE" FOR A LEAD WAS DAMAGED AND 3 OF THE 4 CONDUCTING WIRES WERE BROKEN. IT WAS ALSO STATED THAT THE OTHER LEAD WAS BENT AND A FRACTURE WAS CONFIRMED BY VISUAL INSPECTION. THE PATIENT WAS ABLE TO RECEIVE GOOD PARASTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214771 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention