BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4244043 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21346
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3888-33, LOT# V042634, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-33, LOT# V042634, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3888-45, LOT# V042640, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V042640, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN END OF SERVICE (EOS) OR END OF LIFE (EOL) MESSAGE. THE PATIENT WAS DONE RECHARGING WHEN SHE TRIED TO TURN THERAPY ON AND GOT THE EOS MESSAGE. IT WAS NOTED THAT THE PATIENT ¿MIGHT HAVE SEEN THE MESSAGE BEFORE¿ BUT WAS ABLE TO BYPASS IT AND USE STIMULATION. THE PATIENT SAID HE WAS IN THE HOSPITAL A MONTH PRIOR TO THE REPORT DUE TO A RESPIRATORY ISSUE AND MAY HAVE USED THE STIMULATION 2 -3 WEEKS PRIOR. THE PATIENT REPORTED THAT THEY HAD NOT BEEN IN AN OVERDISCHARGE STATE PREVIOUSLY AND IT DOESN¿T EXPLAIN WHY HE HAD AN IMPLANT THAT ENDED BEFORE THE NINE YEAR MARK. NO INTERVENTION OR OUTCOME WAS REPORTED. FOLLOW UP WAS CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725364 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR