BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2873853 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-11837
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 21, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A LEAD MIGRATION. THE LEADS WERE REVISED. THERE WAS NO INJURY OR ADVERSE EVENT TO THE PATIENT. PATIENT SYMPTOMS INCLUDED LESS THAN 50% THERAPY RELIEF. NO FURTHER INFORMATION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention