BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3845000 · Received June 3, 2014

    Report

    Report Number
    3004209178-2014-10015
    Event Type
    Injury
    Date Received
    June 3, 2014
    Report Date
    May 9, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3487A, LOT # L65524, IMPLANTED: (B)(6) 1999, PRODUCT TYPE LEAD; PRODUCT ID 7495-25, SERIAL # (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE EXTENSION; PRODUCT ID 748925, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 7435, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3487A-33, LOT # J0437237V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER STATED BY THE PATIENTS PHYSICIAN THAT THERE WERE NO MALFUNCTIONS SEEN AND NO CAUSE DETERMINED. THE DEVICE WAS REPLACED ON (B)(6) 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) DID NOT LAST AS LONG AS IT WAS SUPPOSED TO. **INFORMATION OMITTED PERTAINING TO EVENTS (B)(4)- OVER-DISCHARGE/COUPLING, (B)(4) AND (B)(4) REGARDING PRIOR INSS NOT LASTING AS LONG AS THEY SHOULD** ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF REPORTED AND WILL BE UPDATED WHEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324195 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention