BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2940888 · Received February 4, 2013

    Report

    Report Number
    3004209178-2013-01243
    Event Type
    Injury
    Date Received
    February 4, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-45, LOT# V803533010. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3550-39. PRODUCT TYPE: ACCESSORY: PRODUCT ID 3550-29. PRODUCT TYPE: ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-45 LOT# V803533010, EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37754 LOT#, SERIAL # (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3550-39 LOT#, EXPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 3550-29 LOT#,: EXPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. EVALUATION OF THE IMPLANTABLE NEUROSTIMULATOR REVEALED THE FOLLOWING: NO ANOMALY FOUND, SCREW SETS WERE TIGHT AND IN THE CORRECT LOCATIONS. EVALUATION OF THE LEAD REVEALED THE FOLLOWING: TWO CONDUCTORS (CIRCUITS 6 AND 7) BROKEN 2.9 CM FROM THE PROXIMAL END. FUNCTIONAL TEST : (CIRCUIT#:OHMS), 0:4.1, 1: 4.0, 2:3.9, 3:3.8, 4:4.0, 5:3.8, 6:INTERMITTENT, 7:OPEN, NO SHORTS BETWEEN CIRCUITS (DRY). ALSO, TITAN ANCHOR IMPRESSIONS 18.6 TO 19.6 CM FROM THE DISTAL END. EVALUATION OF THE PLUG REVEALED THE FOLLOWING: NO ANOMALY FOUND. EVALUATION OF THE ANCHOR REVEALED THE FOLLOWING: STIM ANCHOR, TITAN ANCHOR, CUT SILICONE.

    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 THERE WAS AN INFECTION IN THE POCKET. THE IMPLANTABLE NEUROSTIMULATOR WAS EXPLANTED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46428 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