BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2130275 · Received June 13, 2011

    Report

    Report Number
    3004209178-2011-04370
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 16, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS ADMITTED TO THE HOSP LAST WEEK FOR WHAT WAS BELIEVED TO BE A HEART ATTACK. THE HOSP PERFORMED A CT SCAN, STRESS TEST, ECG. THE ECG RULED OUT A HEART ATTACK. THE PT STATED THAT HE THOUGHT IT WAS HIS PUMP. HE FELT LIKE AN ANACONDA WAS SQUEEZING HIM AND THAT AN ELEPHANT WAS SITTING ON HIS CHEST. THE PT ALSO EXPERIENCED A RETURN OF SYMPTOMS. THE SYMPTOMS INCLUDED BACK PAIN, COLD SWEATS, BLOOD PRESSURE OF 160/109, AND A HEART RATE OF 100. THE SYMPTOMS STARTED A WEEK BEFORE THE EVENT WAS REPORTED. THE PT STATED THAT THE SYMPTOMS OCCURRED FOLLOWING CLEANING OUT OF THE GARAGE. THE PT'S SYMPTOMS WOKE THE PT UP. THE PT STATED THAT WHEN THEY TAKE ORAL LORAZEPAM AND ORAL PERCOCET TOGETHER, THEY PROVIDE SHORT TERM RELIEF. THE DRUGS IN THE PUMP AT THE TIME OF THE EVENT WERE MORPHINE AND BUPIVICAINE. ADDITIONAL INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8711, LOT# N123404006