BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2851251 · Received November 29, 2012

    Report

    Report Number
    3004209178-2012-10932
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 1, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS HAD MULTIPLE REVISION SURGERIES DUE TO THE LEAD WIRES "MOVING UP HIS BACK." THE PATIENT WAS CONSIDERING HAVING THE STIMULATOR REMOVED AS IT "NEVER REALLY WORKED" FOR HIM. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES A VAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention