BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2050070 · Received March 31, 2011

    Report

    Report Number
    3004209178-2011-02438
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    May 11, 1993
    Report Date
    February 18, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MFR EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.

    Description of Event or Problem · 1

    SEE MFR REPORT # 3004209178-2011-02439. THE STIMULATION STARTED TO BE INTERMITTENT IN (B)(6) 2010. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. AN OUT OF REGULATION (OOR) MESSAGE DISPLAYED ON HER PT PROGRAMMER THIS PAST (B)(6). THE LAST TIME SHE TURNED HER DEVICE ON, IT JUMPED FROM 4.15 TO 5.0 ON ITS OWN. ON TWO DIFFERENT OCCASIONS, HER INS INCREASED AMPLITUDE WITHOUT HER TOUCHING HER PT PROGRAMMER. THERE WAS A POSSIBLE SHORT ON ONE OF THE LEADS. THE BATTERY WAS ABOUT 50% FULL. THE PT WAS SEEN IN THE CLINIC ON (B)(6) 2011. HER CERVICAL LEAD WAS PROGRAMMED ON PROGRAM 1 (0-3) AND THE THORACIC WAS ON PROGRAM 2 (4-7). HER CERVICAL WAS FUNCTIONING FINE, IT WAS THE THORACIC THAT WAS "CUTTING ON AND OFF", ESPECIALLY WITH POSITIONAL CHANGES. HER RECHARGE SESSIONS LOOKED GOOD, WITH GOOD COUPLING AND BATTERY CHARGED TO 75-100% WHEN SHE PRESENTED TO THE CLINIC, HER THORACIC WAS PROGRAMMED 5+, 6-, PW 510, RATE 40. SHE COULD FEEL STIMULATION AT THAT TIME, BUT WANTED TO TRY OTHER PROGRAMMING. MANY COMBINATION WERE TRIED; MOST SHE COULD NOT FEEL ANYTHING, EVEN TURNED UP TO 10.5V. AN IMPEDANCE TEST WAS RAN AT LEAST 4 TIMES AND ALL LOOKED GOOD. THE NUMBER 7 ELECTRODE MAY BE QUESTIONABLE (THE ONLY ELECTRODE AT 1000 OHMS) BUT WAS NEVER USED DURING THE PROGRAMMING SESSIONS, EXCEPT ONCE, IT WAS TRIED. THE DEVICE WAS INTERROGATED WHILE THE PT WAS STANDING, SITTING AND LYING DOWN. THE PT'S DOCTOR FELT THE EQUIPMENT WAS FAULTY AND MENTIONED REPLACING THE DEVICE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA141553N| ADAPTER: MODEL 74001, LOT# N243178| IMPLANTED:| EXTENSION: MODEL 7496, LOT# YR0003304N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# L30791| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE136485N| ACCESSORY: MODEL 37752, LOT# NKA129626N| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37712,| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE150773N| IMPLANTED:| LEAD: MODEL 3586, LOT# LW0008706N| LOT# NKF719883H| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# L57400| EXTENSION: MODEL 7495-51, LOT# XR0014203N| ADAPTER: MODEL 74002, LOT# N231731| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0011517N