BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE UTLRA

    MDR report key: 1870730 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-07883
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 22, 2010
    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). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2010, THE PT WAS HIT IN THE LEFT EYE WITH A 2LB SLEDGE HAMMER WHILE AT WORK, AND THEN WAS HIT IN THE SAME EYE WITH A LID FROM A PRESSURE COOKER THE NEXT WEEK. THE PT BELIEVED THAT SOMETHING WAS WRONG WITH HIS STIMULATOR BECAUSE THE STIMULATION HAD MOVED FROM UNDER HIS LEFT EYE TO HIS LEFT EAR. PRIOR TO THE ACCIDENTS, THE PT WAS GETTING "80-90% PAIN RELIEF". THE PT'S HEALTH CARE PROVIDER (HCP) ORDERED AN X-RAY, WHICH CONFIRMED THAT THE LEAD HAD MIGRATED ALMOST TO THE PT'S EAR. THE LEAD WAS REPLACED ON (B)(6), AND THE PT REPORTED THAT HE HAD "GOOD" STIMULATION. IN (B)(6) IT WAS REPORTED THAT MOTOR RECRUITMENT MADE THE PT'S EYE SHUT WHEN THE POWER WAS TURNED UP HIGH ENOUGH TO HELP WITH THE PAIN. THE PT WAS GETTING 50% PAIN RELIEF USING JUST ENOUGH POWER FOR "SOME RELIEF" AND TO AVOID MOTOR RECRUITMENT. THE LEAD SELECTION WAS ADJUSTED AWAY FROM THE PT'S NOSE. THE PT STATED HE WAS NOW GETTING STIMULATION IN THE NOSE IF THE 567 LEADS WERE "ON". THE PT WAS USING 234 IN A +-+ ARRAY WITH A 540 PW AND 40R. CONTACT NO 7 SHOWED OVER 10K OHMS. THE PT INDICATED THAT HE DID NOT WANT FURTHER SURGERY, THAT HE WAS "GOOD ENOUGH FOR NOW", AND THAT CHARGING WAS EASY AND QUICK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention IMPLANTED:| EXPLANTED:| LEAD: MODEL 3776, LOT # V105303028| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA132115N| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE135240N| EXPLANTED:| LEAD: MODEL 3776, LOT # V244030018| EXPLANTED:| IMPLANTED: