BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2441105 · Received February 7, 2012

    Report

    Report Number
    3004209178-2012-00827
    Event Type
    Malfunction
    Date Received
    February 7, 2012
    Report Date
    January 11, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 377845, LOT# V013770, IMPLANTED: (B)(6) 2007, EXPLANTED: NA; EXTENSION: MODEL# 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: NA; EXTENSION: MODEL# 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: NA. PROGRAMMER: MODEL 37742, SERIAL# (B)(4); RECHARGER: MODEL 37752, SERIAL# (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THERE WAS A PROBLEM WITH THE INS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1