BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 4190610 · Received October 21, 2014

    Report

    Report Number
    3004209178-2014-20121
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    April 23, 2014
    Report Date
    September 30, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 377760, LOT# V006162, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 377760, LOT# V006162, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF PAIN RELIEF AND HIGH IMPEDANCES WERE PRESENT. EXAMINATION AND PALPATION REVEALED THE PARES THESIA TO THE PATIENT¿S LEFT LEG WAS INTERMITTENT. THE EVENT WAS RELATED TO THE LEADS AND NOT RELATED TO THE IMPLANT PROCEDURE. BOTH LEADS WERE REPLACED AND THE EVENT WAS CONSIDERED ONGOING AT THE TIME OF REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE DEVICE WAS INTERROGATED IN SEPTEMBER AND THERE WERE NO IMPEDANCES OUT OF RANGE. EXAMINATION AND PALPATION NOTED PARESTHESIA WAS ADEQUATE. THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667657 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention