BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3010268 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03898
    Event Type
    Injury
    Date Received
    March 19, 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 Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3550-39, LOT# N360894, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: ACCESSORY: PRODUCT ID 3550-29, LOT# N360504, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR LEAD EXPLANTED DUE TO DISCOMFORT AT SPINAL SITE, PAIN, HIGH IMPEDANCES, AND LESS THAN 50% THERAPEUTIC RELIEF ON THE LEFT LOWER EXTREMITY. IT WAS STATED THAT THE INNER TITANIUM CANNULA ON THE LEAD CAME APART FROM THE SILICONE. IT WAS ALSO STATED THAT ELECTRODES 6 AND 7 HAD IMPEDANCES OF GREATER THAN 10 ,000 OHMS. THE PATIENT HAD THE PREVIOUS LEAD REMOVED AND A NEW ONE IMPLANTED, AND WAS REPROGRAMMED. THE PATIENT RECOVERED WITHOUT SEQUELA. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114246 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