BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2614135 · Received June 12, 2012

    Report

    Report Number
    3004209178-2012-04377
    Event Type
    Malfunction
    Date Received
    June 12, 2012
    Report Date
    May 15, 2012
    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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 399945, LOT# V159089, IMPLANTED: (B)(6) 2010; PRODUCT TYPE: LEAD, PRODUCT ID: 3998, LOT# V258459, IMPLANTED: (B)(6) 2010; PRODUCT TYPE: LEAD, PRODUCT ID: 37752, SERIAL# (B)(4); PRODUCT TYPE: RECHARGER, PRODUCT ID: 37743, SERIAL# (B)(4); PRODUCT TYPE: PROGRAMMER, PATIENT, PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010; PRODUCT TYPE: EXTENSION, PRODUCT ID: 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010; PRODUCT TYPE: EXTENSION, PRODUCT ID: 355031, LOT# N241369, IMPLANTED: (B)(6) 2010; PRODUCT TYPE: SCREENING DEVICE, PRODUCT ID: 3550-P4, LOT# N240308, IMPLANTED: (B)(6) 2010; PRODUCT TYPE: ACCESSORY, PRODUCT ID: 3550-39, LOT#: N237162, IMPLANTED: (B)(6) 2010; PRODUCT TYPE: ACCESSORY, PRODUCT ID: 3550-39, LOT#: N237162, IMPLANTED: (B)(6) 2010; PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD MIGHT HAVE BEEN DISCONNECTED. THE MANUFACTURER REPRESENTATIVE WAS NOT ABLE TO COMMUNICATE WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT LAST FELT STIMULATION THREE WEEKS PRIOR TO REPORT. THE PATIENT WAS WORKING WITH HER PHYSICIAN TO DETERMINE WHETHER THE INS NEEDED REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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