BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2471756 · Received February 28, 2012

    Report

    Report Number
    3004209178-2012-01245
    Event Type
    Injury
    Date Received
    February 28, 2012
    Report Date
    January 30, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3888-45 LOT# V331906 IMPLANTED: 2009-11-04 EXPLANTED: NA. LEAD MODEL 3888-45 LOT# V331906 IMPLANTED: (B)(6) 2009 EXPLANTED: NA. LEAD MODEL 3888-45 LOT# V302548 IMPLANTED: (B)(6) 2009 EXPLANTED: NA. LEAD MODEL 3888-45 LOT# V260571 IMPLANTED: (B)(6) 2009 EXPLANTED: NA. EXTENSION MODEL 3708220 SERIAL# (B)(4) IMPLANTED: (B)(6) 2009 EXPLANTED: NA. EXTENSION MODEL 3708240 SERIAL# (B)(4) IMPLANTED: (B)(6) 2009 EXPLANTED: NA. ANCHOR MODEL 3550-39 LOT# N171449 IMPLANTED: (B)(6) 2009 EXPLANTED: NA. ANCHOR MODEL 3550-39 LOT# N137575 IMPLANTED: (B)(6) 2009 EXPLANTED: NA. PROGRAMMER MODEL 37743 SERIAL# (B)(4). RECHARGER MODEL 37752 SERIAL# (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS FOR THE INS REVEALED PART OF THE LEAD WAS STUCK INSIDE THE CONNECTOR PORT. THE CONNECTOR SLEEVES WERE CRUSHED. THE SET SCREW AND GROMMET ARE MISSING FROM THE LOWER PORT. A CONNECTOR SLEEVE IS VISIBLE INSIDE. IT IS THE #1 SLEEVE. THE SET SCREW HAS BEEN OVER-TIGHTENED ON THIS CONNECTOR. THE CONNECTOR SLEEVE HAS BEEN CRUSHED AND IS STUCK IN THE SET SCREW BLOCK. THE #0 CONNECTOR SLEEVE HAS BEEN PULLED OFF AND WAS NOT RETURNED. FINAL DEVICE ANALYSIS FOR EXTENSION (B)(4) REVEALED THE PROXIMAL END CONNECTOR WAS CRUSHED.

    Description of Event or Problem · 1

    THE PHYSICIAN WANTED AN IMPEDANCE CHECK WITH THE INS AND EXTENSION IN THE SNAPLID. THIS COULD NOT BE DONE. THE SETSCREW IN THE INS WOULD NOT RELEASE TO REMOVE THE PNE OF THE EXTENSION. BOTH THE EXTENSION AND INS WERE REPLACED. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA. THE PATIENT WAS DOING WELL WITH HIS THERAPY.

    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 Required Intervention