BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3864206 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11317
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 21, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_SILICONE ANCHOR, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: ACCESSORY. PRODUCT ID: NEU_SILICONE ANCHOR, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: ACCESSORY. (B)(4). ANALYSIS OF THE LEAD (SERIAL # (B)(4)) FOUND NO SIGNIFICANT ANOMALY. THE LEAD BODY INSULATION WAS CUT THROUGH AND THE LEAD WAS SEGMENTED. ANALYSIS OF THE ANCHOR FOUND NO ANOMALY. ANALYSIS OF THE ANCHOR FOUND NO ANOMALY. THERE WAS A COSMETIC DEPRESSION AND MELTING ON THE ANCHOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR LEAD EXPLANTED ON (B)(6) 2013 DUE TO A FAILURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338492 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 Required Intervention