BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3790063 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-08488
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANTABLE NEUROSTIMULATOR SERIAL NUMBER WAS UPDATED BASED ON FURTHER REVIEW.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SUDDEN INCREASE OF VOLTAGE AND WAS NOT ABLE TO REDUCE THE STIMULATION OR TURN OFF THE IMPLANTABLE NEUROSTIMULATOR (INS) WITH THE PATIENT PROGRAMMER. THE PATIENT WAS REPROGRAMMED. IT WAS UNKNOWN IF THERE WERE PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT STATUS WAS REPORTED TO BE ALIVE WITH NO INJURY. THE PATIENT WAS IMPLANTED FOR CLUSTER HEADACHES. ADDITIONAL INFORMATION INDICATED THE PATIENT WAS REPROGRAMMED AND NOW HAD TWO DIFFERENT PROGRAMS. BOTH PROGRAMS HAD UPPER LIMITS TO THE STIMULATION. THE PATIENT WAS GETTING THERAPY AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268536 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR