BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1170703 · Received September 16, 2008

    Report

    Report Number
    3004209178-2008-05797
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING SENSATION FOLLOWING A FALL OR SOME OTHER FORM OF TRAUMA. THE PATIENT STATED SHE "FEELS THIS SENSATION UP HER ENTIRE SPINAL CORD". THE PATIENT WAS AT THE CLINIC WHERE THE HCP REPORTED READING >10000 OHMS ON "JUST A FEW PAIRS". NO FURTHER OUTCOME WAS REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention PROGRAMMER MODEL 37743| EXPLANTED:| LEAD MODEL 3777| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD MODEL 3777