BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 1832251 · Received September 3, 2010

    Report

    Report Number
    3004209178-2010-06757
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    July 22, 2010
    Report Date
    August 5, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LNQ
    PMA / PMN Number
    HDE99015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SEE ALSO MFR REPORT # 3004209178-2010-06696 REGARDING RELATED ISSUE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING/JOLTING SENSATION IN THE HANDS, FEET AND LEGS WHEN SITTING OR STANDING. THESE SYMPTOMS BEGAN IN THE PREVIOUS TWO WEEKS AND WERE LOCATED OVER THE INS SITE. THERE WAS NO KNOWN RELATED INCIDENT OR ACCIDENT REPORTED. THE PATIENT TURNED DOWN THE STIMULATION TO 0.0 VOLTS AND STILL FELT THE JOLT OR SHOCKS. NO FURTHER DETAILS, PATIENT SYMPTOMS OR OUTCOMES WERE PROVIDED. ADDITIONAL INFO WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA LNQ MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR IMPLANTED:| LEAD: MODEL 4351, LOT# NHT008346N| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT008075N