BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4093469 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17120
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 22, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S BATTERY DEPLETED PREMATURELY. THE BATTERY DEPLETED IN LESS THAN A YEAR. THE PATIENT THOUGHT THAT IT SHOULD HAVE LASTED LONGER. THE PATIENT HAD NO STIMULATION. THE DEVICE HAD REACHED END OF SERVICE (EOS). THE PATIENT WAS IN CONTINUOUS STIMULATION MODE. THE PATIENT WAS TOLD THEY HAD THE OPTIONS OF DOING NOTHING, EXPLANTING THE DEVICE, OR REPLACING THE DEVICE. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014 TO DISCUSS THEIR OPTIONS. 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
    571082 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97702

    Patients

    Seq Age Sex Outcome Treatment
    1