BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4795042 · Received May 26, 2015

    Report

    Report Number
    3004209178-2015-09639
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 7, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LEFT HIS STIMULATOR ON FOR 2 DAYS AND NOW THE STIMULATOR BATTERY HAS COMPLETELY DEPLETED. THE PATIENT STARTED RECHARGING LAST NIGHT AND WAS HALFWAY FULL NOW AT THE TIME OF THIS REPORT. THE PATIENT FELT THAT THE BATTERY LEVEL SHOULD LAST LONGER THAN 2 DAYS AND DOES NOT KNOW IF HE IS DOING SOMETHING WRONG OR SHOULD NOT LEAVE THE STIMULATOR ON FOR THAT LONG. A PRODUCT SERVICE SPECIALIST REVIEWED THAT IT DEPENDS ON THE SETTINGS AND USAGE OF THE DEVICE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT.  SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339236 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR