BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 5192998 · Received October 30, 2015

    Report

    Report Number
    3004209178-2015-21962
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 6, 2015
    Report Date
    April 26, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 9 77A260, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID 977A260, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER (HCP) REPORTED THE DEVICE WAS NOT WORKING. THE HCP WANTED TO SET UP A TIME FOR A MANUFACTURER'S REPRESENTATIVE (REP) TO CHECK THE PATIENT'S DEVICE. NO PATIENT SYMPTOMS WERE REPORTED. NO INTERVENTIONS OR OUTCOMES WERE REPORTED REGARDING THIS EVENT. 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

    THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT WAS UNABLE TO CHARGE. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS OVERDISCHARGED AND WAS CONFIRMED VIA THE CLINICIAN PROGRAMMER. THERE WERE NO KNOWN FACTORS THAT CONTRIBUTED TO THIS ISSUE. A TRICKLE CHARGE WAS PERFORMED AND RESOLVED THE ISSUE. SURGICAL INTERVENTION HAD NOT OCCURRED, NOR WAS IT PLANNED. THE INS WAS RESET AND GOT GOOD COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721020 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97712

    Patients

    Seq Age Sex Outcome Treatment
    1