BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3172570 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10431
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 23, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    INITIALLY REPORTED FOR SERIOUS INJURY. AFTER ADDITIONAL REVIEW THERE ARE NO INDICATIONS OF SERIOUS INJURY. REPORTABLE FOR MALFUNCTION ONLY. OUTCOME ATTRIBUTED TO ADVERSE EVENT: REMOVED INTERVENTION REQUIRED AS THIS WAS NOT A SERIOUS INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURING REPRESENTATIVE WAS ABLE TO REPROGRAM THE PATIENT. PATIENT WAS NO LONGER FEELING SHOCKING BETWEEN HIS SHOULDER BLADES.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A SHOCKING SENSATION IN HIS UPPER BACK AREA BETWEEN THE SHOULDER BLADES. THE LEAD WAS PLACED AT THE THORACIC LEVEL FOR LOWER EXTREMITIES STIMULATION. HIS DOCTOR ATTEMPTED INJECTIONS TO COVER THE PAIN AND THE DEVICE WAS REPROGRAMMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273216 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