BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY VERSITREL

    MDR report key: 3162685 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10148
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 16, 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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS EZW. CONCOMITANT PRODUCTS: PRODUCT ID 748910, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 748910, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 7435, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT # V434086, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3093-28, LOT # V434086, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT WERE WORKING WITH THEIR HEALTHCARE PROFESSIONAL OR MANUFACTURER REPRESENTATIVE. IT WAS NOTED AN APPOINTMENT HAD NOT BEEN MADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MET A MANUFACTURE REPRESENTATIVE AND HER DEVICE WAS CHECKED. IT WAS FOUND THAT ONE OF THE PATIENT¿S ¿LEAD WIRES ARE BROKEN OFF.¿ THE PATIENT STATED THAT SINCE AN UNRELATED SURGERY THAT SHE HAD (B)(6) 2012, HER SYMPTOMS HAVE GOTTEN WORSE AND THE THERAPY SEEMED NOT TO BE AS EFFECTIVE. THE PATIENT NOTED THAT PART OF THAT SURGERY WAS ¿THEY HAD TO LIFT HER BLADDER.¿ THE PATIENT STATED THAT ¿THERE WERE A LOT OF FACTORS TO CONSIDER.¿ THE PATIENT DID NOT KNOW WHEN THE LEAD BROKE SO WAS NOT SURE IF THAT WAS THE ¿MAIN FACTOR¿ FOR HER THERAPY CHANGE. THE PATIENT MENTIONED THAT THE FIRST TWO YEARS OF HER THERAPY WERE GOOD AND SHE FELT THE DEVICE HELPED HER SYMPTOMS. THE PATIENT STATED THAT SHE NEEDED TO GET ¿THE ISSUES¿ SORTED OUT WITH HER HEALTH CARE PROVIDER (HCP) TO SEE WHAT WAS FACTORING IN TO THE THERAPY NOT WORKING AS WELL AS IT USED TO. 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
    263269 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427V-NP

    Patients

    Seq Age Sex Outcome Treatment
    1