BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3022068 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04269
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 14, 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 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED "STOMACH STIMULATION." IT WAS FURTHER REPORTED THAT IT WAS BELIEVED THAT THE PATIENT'S LEAD "WAS WRAPPED AROUND HIS CORD" AND THAT THIS WAS THE CAUSE OF THE STIMULATION. THE REVISION WAS REPORTED TO HAVE OCCURRED ON (B)(6) 2013 DUE TO "LEAD MIGRATION." THE EXACT NATURE OF WHAT WAS DONE DURING THE REVISION WAS UNKNOWN AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REVEALED THERE WAS A MEETING ON (B)(6) 2013, FOLLOWING THE LOSS OF STIMULATION RESULTS. AT THAT TIME, IMPEDANCE MEASUREMENT WERE WITHIN NORMAL LIMITS. PATIENT EDUCATION WAS PROVIDED ON INCREASING VOLTAGE VIA THE PATIENT PROGRAMMER. THE PATIENT REPORTED PROPER STIMULATION FOLLOWING THE APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123233 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention