BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1922926 · Received November 9, 2010

    Report

    Report Number
    3004209178-2010-09104
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE IMPLANTABLE NEUROSTIMULATOR HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL WAS UNABLE TO ADVANCE THE LEAD INTO THE 8-15 PORT. TROUBLESHOOTING WAS PERFORMED WITHOUT SUCCESS INCLUDING BACKING OUT THE SCREW AND TRYING AGAIN, AND TRYING BOTH "TAILS" OF THE 5-6-5 LEAD. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT IMPLANTED. A NEW INS WAS OPENED AND THE LEAD TAILS ADVANCED WITHOUT DIFFICULTY. ALL IMPEDANCES WERE WITHIN NORMAL RANGE. THE PT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR IMPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL WRENCH, LOT# UNK