BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3001930 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03634
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 26, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_SILICONEANCHOR. PRODUCT TYPE: ACCESSORY: PRODUCT ID 39565, LOT# V499618041. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE NEUROSTIMULATOR REVEALED THE FOLLOWING: THERE WERE NO SIGNIFICANT ANOMALIES FOUND. THE BATTERY WAS PERMANENTLY DAMAGED FROM BEING OVER-DISCHARGED. FINAL DEVICE ANALYSIS OF THE LEAD REVEALED THE FOLLOWING: THERE WERE NO SIGNIFICANT ANOMALIES FOUND. THE BODY OF THE LEAD WAS FOUND SEGMENTED. FINAL DEVICE ANALYSIS OF THE ANCHOR REVEALED THE FOLLOWING: THERE WERE NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD "FAILED." THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD WERE EXPLANTED. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105844 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