BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 3162926 · Received June 11, 2013

    Report

    Report Number
    3007566237-2013-01934
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 20, 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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7495LZ25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION; PRODUCT ID 7495LZ25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION; PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3487A-33, LOT# J0214174V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD; PRODUCT ID 3487A-33, LOT# J0214174V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. THE INITIAL MDR WAS FILED AS MFG. REPORT # 3007566237-2013-01934. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE CORRECT MANUFACTURING SITE WAS SITE # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED SERIOUS PERSONAL INJURIES FOLLOWING THE FAILURE OF A SPINAL STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261839 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other