BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME

    MDR report key: 2904906 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00382
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 18, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE PROGRAMMER, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S SPINAL CORD STIMULATION SYSTEM HADN'T WORKED AND SHE HAD HAD IT REMOVED. THE SYSTEM DID NOT ADDRESS THE PATIENT'S PAIN NEEDS 'AT ALL.' IT WAS UNKNOWN WHEN THE DEVICE HAD BEEN EXPLANTED BUT IT WAS THOUGHT THAT IT HAD BEEN TAKEN OUT SOMETIME IN 2011. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12427 RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37701

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention