BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3840920 · Received May 30, 2014

    Report

    Report Number
    3007566237-2014-01489
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 8, 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
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_ADAPTOR_ACC, LOT# UNKNOWN, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS INVOLVED IN A CAR COLLISION AND SINCE THEN, THE EFFECTIVENESS OF THE THERAPY HAD DIMINISHED. IT HAD GOTTEN TO THE POINT WHERE THE PATIENT COULD NOT FEEL ANY STIMULATION AT ALL. IMPEDANCE MEASUREMENTS WERE HOWEVER ALL FINE. THE IMPACT FROM THE ACCIDENT WAS ON THE OPPOSITE SIDE OF THE IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANT SITE. ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT WAS NOT RECEIVING THERAPY AND WAS AWAITING AN APPOINTMENT WITH THE NURSE FOR FURTHER TROUBLESHOOTING SUCH AS RUNNING AN IMPEDANCE CHECK WHILE MANIPULATING THE POCKET/ADAPTOR SITE

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT WHEN THE NURSE RAN IMPEDANCE CHECKS WHILE MANIPULATING THE PATIENT¿S POCKET ADAPTOR AND CONNECTIONS THERE WAS ¿NO DIFFERENCE TO THE IMPEDANCE READINGS.¿ IT WAS STATED THE PATIENT WAS ¿RECEIVING SOME THERAPY FROM ONE OF HER LEADS AT VERY HIGH VOLTAGES (MUCH HIGHER THAN BEFORE)¿ AND THAT HER ¿STIMULATION WAS NOT ADEQUATE FOR PAIN RELIEF¿ AT THE TIME OF FOLLOW-UP. IT WAS NOTED IT WAS PLANNED TO REPLACE THE PATIENT¿S LEADS, HOWEVER NO DATE HAD BEEN CONFIRMED AT THE TIME OF FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318317 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention