BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2800296 · Received October 22, 2012

    Report

    Report Number
    3004209178-2012-09410
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Report Date
    September 24, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708240 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3487A-45 LOT# V419202, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3487A-45 LOT# V506763, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE STIMULATION WAS "NOT WORKING" AND THAT THE PATIENT COULD NOT RECHARGE THE IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) 2012. APPROXIMATELY ONE MONTH LATER IT WAS REPORTED, THE PATIENT HAD COUPLING AND COMMUNICATION ISSUES. THE PATIENT HAD NOT BEEN ABLE TO GET MORE THAN 2 BARS COUPLING AND IT WOULD "TAKE DAYS TO CHARGE." THE INS WAS REPORTED TO BE SUPERFICIAL AND IT WAS STATED THE INS MAY BE FLIPPED, BUT IT WAS NOT CONFIRMED. APPROXIMATELY 6 WEEKS LATER, THE DAY OF REPORT, IT WAS REPORTED THAT THE INS WAS FLIPPED. THE PATIENT REFUSED TO HAVE EVALUATION/X-RAY TO DETERMINE INS PLACEMENT AND WOULD FOLLOW UP WITH HER PHYSICIAN ON A "NEED BASIS." THE INS COULD NOT BE CHARGED. NO SURGICAL INTERVENTION HAD BEEN DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1