BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2591723 · Received May 30, 2012

    Report

    Report Number
    3004209178-2012-03805
    Event Type
    Injury
    Date Received
    May 30, 2012
    Report Date
    May 4, 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

    LEAD MODEL 399930, LOT # V010129, IMPLANTED: (B)(6) 2006, EXPLANTED: NA; EXTENSION MODEL 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: NA; PROGRAMMER MODEL 37743, SERIAL # (B)(4); RECHARGER MODEL 37752, SERIAL # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED TELEMETRY ISSUES. AN OVERDISCHARGE WAS SUSPECTED. THE PATIENT HAD EXPERIENCED A PREVIOUS OVERDISCHARGE, AND THE NEUROSTIMULATOR WAS ONLY LASTING A DAY OR TWO BEFORE NEEDING RECHARGING. THE LAST TIME ANY STIMULATION WAS FELT WAS 2 TO 6 MONTHS AGO. THE LAST SUCCESSFUL RECHARGE SESSION WAS 2 TO 6 MONTHS AGO. FOLLOWING THE SECOND OVERDISCHARGE, THE BATTERY WOULD NOT HOLD A CHARGE LONGER THAN A DAY, AND THE PATIENT DECIDED TO REPLACE THE BATTERY WITH A PRIMARY CELL. THE PATIENT'S HUSBAND HAD MEDICAL ISSUES, AND IT WAS REPORTED THAT IT MAY BE A WHILE BEFORE THE PATIENT HAD HER REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention