BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3199276 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-11101
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    June 11, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-39, LOT# N153262, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013,: PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3550-39, PRODUCT TYPE: ACCESSORY. (B)(4). FINAL DEVICE ANALYSIS FOR LEAD V378915019 REVEALED ALL THE CONDUCTORS WERE BROKEN AT THE TITAN ANCHOR SITE, 13.5CM FROM THE DISTAL END. FINAL DEVICE ANALYSIS FOR LEAD V400941025 REVEALED ALL THE CONDUCTORS WERE BROKEN AT THE TITAN ANCHOR SITE, 19CM FROM THE DISTAL END. FINAL DEVICE ANALYSIS FOR ANCHOR (B)(4) REVEALED THE TITANIUM INSERT SEPARATED FROM THE SILICONE. FINAL DEVICE ANALYSIS FOR THE UNKNOWN ANCHOR REVEALED NO ANOMALY FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEADS FRACTURED. THE LEADS WERE EXPLANTED AND WHILE EXPLANTING THE ANCHORS WERE DAMAGED. THE PATIENT HAD A LOSS OF STIMULATION FOLLOWING A ¿DEMONSTRATION OF TAKE DOWN AT WORK DEALING WITH AGGRESSIVE TEENS.¿ THE PATIENT WAS A DEMONSTRATOR AND THOUGHT THE LEAD DAMAGE OCCURRED AT THE TIME OF THE TAKE DOWN. THE PATIENT SYMPTOMS WERE LESSTHAN 50% THERAPY RELIEF. BOTH LEADS WERE REMOVED AND REPLACED. THE PATIENT WAS EXPERIENCING FULL COVERAGE OF STIMULATION FOLLOWING THE INTERVENTION ON (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTED LEFT LEG PAIN TO FOOT. IT WAS NOTED ALL ELECTRODES WERE OUT OF RANGE, GREATER THAN 10,000 OHMS. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299182 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention