BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 3833595 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09651
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    May 6, 2014
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3998, LOT# J0427920V, PRODUCT TYPE: LEAD; PRODUCT ID 748925, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION; PRODUCT ID 748925, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION; PRODUCT ID 7435, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S FIRST IMPLANTABLE NEUROSTIMULATOR (INS) THAT WAS IMPLANTED IN 2005 WAS NOT EFFECTIVE SO IT HAD TO BE REDONE. IT WAS NOTED THE PATIENT DID NOT HAVE A CURRENT FOLLOW UP HEALTHCARE PROFESSIONAL. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310440 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 Required Intervention