BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 6794644 · Received August 15, 2017

    Report

    Report Number
    3004209178-2017-17476
    Event Type
    Injury
    Date Received
    August 15, 2017
    Report Date
    August 15, 2017
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3487A-56, LOT# V132262, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V132262, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-56, LOT# V133823, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-56, LOT# V133823, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR CERVICAL/NECK ISSUES AND POST LAMINECTOMY PAIN. THE HCP STATED THAT THE PATIENT CAME TO THEM BECAUSE THEIR INS NEVER WORKED FOR THEM. THE HCP TOOK AN X-RAY OF THE SYSTEM WHICH SHOWED THAT THE LEADS WERE PULLED OUT OF THE EPIDURAL SPACE IF THAT IS WHERE THEY WERE IMPLANTED ORIGINALLY. THE HCP WAS PLANNING TO EXPLANT THE SYSTEM. THE HCP WOULD PAGE A MANUFACTURE REPRESENTATIVE (REP). NO FURTHER COMPLICATIONS WERE REPORTED/ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574556 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