BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2431763 · Received January 30, 2012

    Report

    Report Number
    3007566237-2012-00192
    Event Type
    Malfunction
    Date Received
    January 30, 2012
    Date of Event
    December 16, 2011
    Report Date
    December 16, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXTENSION MODEL # 37082 LOT # NKB102482V IMPLANTED 2011-(B)(6) EXPLANTED 2011-(B)(6); LEAD MODEL # 3888 LOT # V780541 IMPLANTED 2011-(B)(6) EXPLANTED 2011-(B)(6); LEAD MODEL # 3888-45 LOT # V780541 IMPLANTED 2011-(B)(6) EXPLANTED N/A; LEAD MODEL # 3888-45 LOT # V778998 IMPLANTED 2011-(B)(6) EXPLANTED N/A; EXTENSION MODEL # 3708220 LOT # NKB012564V IMPLANTED 2011-(B)(6) EXPLANTED N/A; PROGRAMMER MODEL # 37743 LOT # NKE177640N; RECHARGER MODEL # 37752 LOT # NKA159610N; LEAD MODEL # 3778-60 LOT # V858753026 IMPLANTED 2011-(B)(6) EXPLANTED N/A.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF EXTENSION MODEL # 37082, LOT # NKB102482V, SHOWED DISTAL END/CONNECTOR/TWISTED IN MOLDED RUBBER. THREE SEGMENTS RETURNED: PROXIMAL, MEDIAL, AND DISTAL. SEGMENT # 1 INCLUDE PROXIMAL END AND ELECTRODE LEG WITH CIRCUITS #4-7. CONDUCTOR(S) CUT. BODY INSULATION CUT THRU, EXTENSION SEGMENTED. DISTAL END OBSERVATIONS: CONNECTOR(S) CUT OFF. SETSCREW(S) MISSING. CIRCUIT # 3, A KNOWN GOOD SETSCREW WAS ABLE TO BE FULLY INSERTED INTO THE CONNECTOR BLOCK. NO SHORTS BETWEEN CIRCUITS. FINAL ANALYSIS OF LEAD MODEL # 3888, LOT # V780541, SHOWED PROXIMAL END STRETCHED. COMPLETE LEAD RETURNED. SETSCREW MARK OBSERVATIONS: IN CORRECT LOCATION. NO SHORTS BETWEEN CIRCUITS; CONTINUITY ACCEPTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, AS THE SURGEON WAS SCREWING DOWN THE LAST SETSCREW ON THE (B)(4) EXTENSION, THE SETSCREW TURNED VERTICAL TO HORIZONTAL ON THE LAST ELECTRODE, AND THEY COULD NOT GET BACK TO VERTICAL POSITION. IN THE PROCESS, THE (B)(4) LEAD WAS DAMAGED FROM THE SETSCREW. (FAULTY SET SCREW ON EXTENSION RESULTED IN DAMAGE TO LEAD. LEAD/EXTENSION: BREAKAGE/DISLODGMENT. ) ANOTHER LEAD ((B)(4)) WAS USED WITH A NEW EXTENSION ((B)(4)) WITHOUT ANY ISSUE. THE PATIENT WAS DOING WELL; RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR