BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2972116 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-02947
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    January 31, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE PATIENT'S PHYSICIAN REPORTED THE CAUSE OF THE EVENT AS "UNKNOWN". IT WAS FURTHER NOTED THE PATIENT HAD "NOT REQUESTED TO BE SEEN FOR REPROGRAMMING OF THE DEVICE OR TO FOLLOW-UP" WITH THE PATIENT'S PHYSICIAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELT POSITIONAL CHANGES THAT WERE "DIFFERENT THAN ANYTHING HE HAD FELT PREVIOUSLY" AFTER A FALL THE WEEKEND PRIOR TO REPORT. THE REPORTER STATED THAT THE PATIENT "TWISTED HIS BODY PRETTY GOOD" AND HIS SYMPTOMS WERE "BORDERLINE PAINFUL." IT WAS REPORTED THAT THE PATIENT TURNED HIS STIMULATION DOWN FOR COMFORT. THE PATIENT TRIED TO CONTACT HIS HEALTHCARE PROVIDER BUT HAD NOT BEEN ABLE TO REACH THEM AT THE TIME OF THE REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77426 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