BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4131540 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18038
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39565-65, LOT# VA0JVSS, PRODUCT TYPE: LEAD. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE ISSUE WITH THE PATIENT¿S STIMULATION TURNING OFF WAS DUE TO BE A ¿FLAT FINGER¿ ISSUE. THE SYNC AND ON/OFF BUTTONS ON THE PATIENT PROGRAMMER ARE CLOSE TO ONE ANOTHER WHICH ALLOWS THE PATIENT TO INADVERTENTLY TURN OF THE IMPLANTABLE NEUROSTIMULATOR (INS) ESPECIALLY WHEN THEY TRY CHANGING PROGRAMS AT NIGHT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE WOULD OCCASIONALLY TURN OFF WHILE SLEEPING. THIS HAD OCCURRED AT LEAST THREE TIMES SINCE ACTIVATION AFTER IMPLANT, WHICH WAS APPROXIMATELY (B)(6) 2014. NO TROUBLESHOOTING HAD BEEN PERFORMED FOR THIS ISSUE. NO INTERVENTIONS OR OUTCOME 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610245 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1