BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 1150423 · Received September 5, 2008

    Report

    Report Number
    3004209178-2008-05486
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    November 1, 2006
    Report Date
    August 7, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LNQ
    PMA / PMN Number
    HDE99015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SEE ALSO MANUFACTURER REPORTS 3004209178200600945 AND 3004209178200805491. IT WAS REPORTED THAT SINCE THE PATIENT'S DEVICE WAS RELOCATED FROM THE LEFT TO THE RIGHT SIDE OF HER BODY IN 2006 SHE HAS HAD PERSISTENT SEVERE ABDOMINAL PAIN. IN SEVEN MONTHS LATER, THE PATIENT'S LEADS WERE REPLACED AND REPOSITIONED. AFTER APPROXIMATELY SIX HOURS THE SURGERY WAS COMPLETE AND THE PATIENT WAS PLACED INTO INTENSIVE CARE. HER CHEST FELT HEAVY AND NUMB, AND HER LEGS WERE NUMB AS WELL. SHE EXPERIENCED MAJOR TACHYCARDIA, SPASTICITY, AND TREMORS. SHE WAS ON OXYGEN AND HAD DIFFICULTY TIME BREATHING. FOLLOW-UP WITH THE PHYSICIAN REVEALED THAT A PULMONARY EMBOLISM WAS RULED OUT AND THE PATIENT WAS DOING BETTER AND STABILIZED. SCOPOLAMINE HAD BEEN ADMINISTERED TO THE PATIENT AND THE PHYSICIAN BELIEVED THIS WAS THE CAUSE OF THE TACHYCARDIA. NO FURTHER INFORMATION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R IMPLANTED:| STIM ACCESSORY MODEL 4351 LOT# NHT004462N| IMPLANTED:| STIM ACCESSORY MODEL 4351 LOT# NHT004461N| EXPLANTED:| EXPLANTED: