BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6562161 · Received May 11, 2017

    Report

    Report Number
    3004209178-2017-10159
    Event Type
    Malfunction
    Date Received
    May 11, 2017
    Date of Event
    May 8, 2017
    Report Date
    May 11, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 977A260, LOT # VA15YBB017, SERIAL # (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE LEAD; PRODUCT ID 977A260, LOT # VA17ANQ017, SERIAL # (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED VIA A MANUFACTURER REPRESENTATIVE FROM A HEALTH CARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT COMPLAINS OF INCREASED PAIN IN THE LOWER BACK AND RADIATING UP THE SPINE. THE HEALTH CARE PROVIDER HAS RULED OUT STIMULATION AS THE CAUSE AS THE PATIENT HAS RECENTLY BEEN DISCHARGED FROM HER PAIN PRACTICE AND IS NO LONGER RECEIVING MEDICATION. HE FEELS THE PATIENT SAYS THE STIMULATION IS WORKING WELL AND THAT THERE IS NO REASON TO SUSPECT THAT IT IS CAUSING THE ISSUE. THE PATIENT DOES NOT RECALL ANY EVENTS THAT HAVE AFFECTED THE STIMULATOR. THE HEALTH CARE PROVIDER IS ALSO UNAWARE OF ANYTHING THAT MAY HAVE CHANGED THE PATIENT¿S STATUS. THE BATTERY INTERROGATES FINE AND ALL CONNECTIONS APPEAR TO BE WORKING FINE; HOWEVER THE HEALTH CARE PROVIDER TOOK X-RAYS SHOWING ONE LEAD EPIDURAL AND THE OTHER APPEARS COILED AND MIGRATED SUB-CUTANEOUS NEAR THE BATTERY POCKET. THIS APPEARS TO HAVE BEEN AN ISSUE BEFORE AS HER PREVIOUS MANUFACTURER REPRESENTATIVE PROGRAMMED ONLY ON ONE LEAD (THE EPIDURAL ONE). THE MIGRATION DOESN¿T APPEAR TO BE AFFECTING THE PATIENT¿S COVERAGE, SO THE HEALTH CARE PROVIDER DOES NOT WISH TO DO ANYTHING AT THIS TIME. SINCE THE PATIENT IS NOT COMPLAINING OF POOR STIMULATION COVERAGE WITH THE ONE EPIDURAL LEAD, THE HEALTH CARE PROVIDER DOES NOT WANT TO ATTEMPT A REVISION AT THIS POINT UNTIL HER OTHER PAIN IS UNDER CONTROL. THE HEALTH CARE PROVIDER DOES NOT SEE THE NEED FOR ANY FOLLOW-UP. A SURGICAL INTERVENTION WAS NOT PLANNED OR PERFORMED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343118 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR