BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 3082135 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-06985
    Event Type
    Death
    Date Received
    April 29, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8590-1, LOT# N159497, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: ACCESSORY: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY. ANALYSIS OF THE CATHETER REVEALED NO SIGNIFICANT ANOMALY, ACCEPTABLE TESTING, CATHETER WAS INCOMPLETE, RETURNED IN SEGMENTS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HCP REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN AND THE HCP REQUESTED THE DEVICE BE INTERROGATED. IT WAS LATER REPORTED THE TOXICOLOGY SCREEN RESULTS WERE STILL PENDING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP INDICATED THAT THE PATIENT DIED FROM MEDICATION DISORDER. THE PATIENT WAS OVERINTOXICATED WITH THE DRUG PHENYLVANLAFAXINE (EFFEXOR). THE MEDICATION WAS NOT IN THE DEVICE. IT HAD BEEN RULED NON-DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS FOUND DEAD ON (B)(6) 2013 IN RESIDENCE DURING WELFARE CHECK. THE PUMP WAS EXPLANTED DURING AUTOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185940 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Death