BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 4345874 · Received December 19, 2014

    Report

    Report Number
    3004209178-2014-24274
    Event Type
    Injury
    Date Received
    December 19, 2014
    Report Date
    November 26, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WITH FDA CODE LGW AND PMA CODE P840001 WAS USED FOR AN OFF-LABEL INDICATION: URINARY DYSFUNCTION/SACRAL NERVE STIM. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V536681, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3889-28, LOT# V536681, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3889-28, LOT# V471354, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 7435, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION; PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION; PRODUCT ID 3889-28, LOT# V471354, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HAVING A LEFT LEAD REVISION DONE THE DAY OF REPORT. IT WAS NOTED THAT THE PATIENT HAD BILATERAL LEADS AND THIS WAS A SYSTEM UPGRADE OF THE LEFT LEAD AND THE RIGHT LEAD WAS LEFT IN PLACE. AFTER THE LEFT LEAD WAS REPLACED THE PATIENT¿S STIMULATION WAS GOOD POST-OPERATIVELY. IT WAS UNKNOWN WHY THE REVISION WAS REQUIRED AND FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED PATIENT WAS NOT GETTING 50% OR GREATER SYMPTOM REDUCTION. THE ISSUE REPORTED WAS INCREASED IMPEDANCES ON THE LEFT LEAD. THE PATIENT REPORTED DIFFICULTY URINATING AND INCREASED INCONTINENCE. THE CAUSE OF THE EVENT WAS NOT DETERMINED AND WAS REPORTED AS UNKNOWN IF DEVICE RELATED. THE PATIENT CONTINUED TO HAVE URINARY ISSUES DESPITE THE NEW LEAD AND REPROGRAMMING. THE PATIENT OUTCOME WAS REPORTED AD RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835456 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 Required Intervention