BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2335893 · Received November 14, 2011

    Report

    Report Number
    3004209178-2011-09146
    Event Type
    Injury
    Date Received
    November 14, 2011
    Report Date
    November 23, 2011
    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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD MODEL 3487A-45 LOT UNKNOWN FOUND BROKEN CONDUCTORS IN THE LEAD BODY AT THE TITAN ANCHOR SITE, 23.5CM AND 22CM FROM THE DISTAL END. ALL CIRCUITS WERE OPEN. ANALYSIS OF THE ANCHOR MODEL 3550-39 LOT UNKNOWN FOUND NO SIGNIFICANT ANOMALY.

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3487A-45 LOT# V060158 IMPLANTED: 2007-(B)(6) EXPLANTED: 2012-(B)(6), LEAD MODEL 3487A-45 LOT# V016608 IMPLANTED: 2007-(B)(6) EXPLANTED: 2012-(B)(6), LEAD MODEL 3487A-45 LOT# V016608 IMPLANTED: 2007-(B)(6) EXPLANTED: 2012-(B)(6), LEAD MODEL 3487A-45 LOT# V067310 IMPLANTED: 2007-1(B)(6) EXPLANTED: 2012-(B)(6), ACCESSORY MODEL 3550-29 LOT# N153073 IMPLANTED: 2010-(B)(6) EXPLANTED: UNKNOWN, EXTENSION MODEL 3708240 (B)(4) IMPLANTED: 2007-(B)(6) EXPLANTED: 2012-(B)(6), EXTENSION MODEL 3708240 (B)(4) IMPLANTED: 2007-(B)(6) EXPLANTED: 2012-(B)(6). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ACCESSORY MODEL 3550-29, LOT# N153073, IMPLANTED: 2010-(B)(4), EXPLANTED: UNKNOWN, LEAD MODEL 3487A-45, LOT# V060158, IMPLANTED: 2007-(B)(4), EXPLANTED: LEAD, MODEL 3487A-45, LOT# V016608, IMPLANTED: 2007-(B)(4), EXPLANTED: LEAD, MODEL 3487A-45, LOT# V067310, IMPLANTED: 2007-(B)(4), EXPLANTED: EXTENSION, MODEL 3708240, SERIAL# (B)(4), IMPLANTED: 2007-(B)(4), EXPLANTED: RECHARGER MODEL 37752, SERIAL# (B)(4), PROGRAMMER MODEL (B)(4), SERIAL# (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS IN A MOUNTAIN BIKE ACCIDENT IN (B)(6), THOUGH HE DID NOT LOSE STIMULATION UNTIL SOMETIME LATER. REPROGRAMMING WAS NOT ATTEMPTED AS ALL CONTACTS HAD OUT OF RANGE IMPEDANCES. NO OTHER DIAGNOSTICS WERE PERFORMED. THE PATIENT'S LEAD WAS EXPLANTED DUE TO BREAKAGE, AND WAS NOT REPLACED. THERE WAS NO INJURY, AND THE PATIENT RECOVERED WITHOUT SEQUELA. THE MANUFACTURER'S DEVICE REGISTRY SHOWED THAT THE PATIENT'S ENTIRE SYSTEM WAS EXPLANTED. IT WAS UNKNOWN WHY THE REST OF THE SYSTEM WAS EXPLANTED. IT WAS NOTED THAT THE PATIENT WOULD BE SCHEDULED FOR RE-IMPLANT AT A LATER DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT ONLY THE LEAD WAS EXPLANTED. THE BATTERY WAS GOING TO BE REPLACED WHEN THE NEW LEAD IS IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW DETERMINED THIS EVENT WAS ALSO REPORTED UNDER MFR. REP. # 3004209178-2011-09746. ALL FUTURE FOLLOW-UP WILL BE CONDUCTED UNDER THIS MFR. REP. (# 3004209178-2011-09146).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT HIGH IMPEDANCES (>3600 OHMS) WERE MEASURED ON ALL ELECTRODE COMBINATIONS ON THE PATIENT'S NEUROSTIMULATOR. IT WAS NOTED THAT HE PATIENT HAD NOT FELT THEIR STIMUALTION IN OVER A MONTH. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS CONSULTING WITH HIS HCP ABOUT A REVISION, BUT NO SURGERY DATE HAD BEEN SCHEDULED. IT WAS NOTED THAT THE PATIENT WAS NOT RECEIVING THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION APPROXIMATELY 8 SECONDS AFTER HE TURNED ON THE IMPLANTABLE NEUROST IMULATOR. FOLLOWING THE SHOCK THE PATIENT DID NOT FEEL STIMULATION, NO MATTER WHAT SETTING THE DEVICE WAS ON. THE ISSUE BEGAN OCCURRING TWO TO THREE DAYS BEFORE THE REPORT, AND THERE WAS NO REPORTED TRAUMA OR FALLS.

    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 Required Intervention