BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3800127 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08724
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    February 19, 2014
    Report Date
    April 16, 2014
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_TLOCK_ANCHOR, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3777-60, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4). DEVICE ANALYSIS FOR LEAD 3777-60 REVEALED NO SIGNIFICANT ANOMALY. THE LEAD BODY WAS CUT THRU, PRODUCT WAS SEGMENTED. DEVICE ANALYSIS FOR THE ANCHOR REVEALED NO SIGNIFICANT ANOMALY. THERE WERE SUSPECTED TOOL MARKS.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE PATIENT LOSS ALL STIMULATION TO ALL PAINFUL AREAS. THE LEAD WAS REPLACED. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278709 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention