BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3827727 · Received May 22, 2014

    Report

    Report Number
    3004209178-2014-09496
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 10, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 8578, LOT# N120748, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF CATHETER SERIAL #(B)(4) REVEALED ACCEPTABLE TESTING. THIS CATHETER WAS RETURNED IN SEGMENTS. ANALYSIS OF CATHETER SERIAL # (B)(4) REVEALED CORING/CUTS/TEARS IN THE SEAL OF THE SUTURELESS CONNECTER, WHICH POSSIBLY CAUSED THE OCCLUSION. THERE WAS NO MISALIGNMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER REPLACEMENT OCCURRED ON (B)(6) 2014 DUE TO A SUSPECTED CATHETER ISSUE. PER THE PATIENT, THE MANAGING PHYSICIAN ATTEMPTED TO ACCESS THE CATHETER ACCESS PORT (CAP) IN THE CLINIC BUT WAS UNABLE TO DUE TO SCAR TISSUE. THE PATIENT HAD EXPERIENCED SYMPTOMS OF NAUSEA, SWEATING, INCREASED TONE AND FEELING ¿MISERABLE¿ SINCE HER PUMP REPLACEMENT SURGERY. THE PUMP WAS REPLACED ON (B)(6) 2014 AND THE DATE OF THE EVENT WAS REPORTED AS (B)(6) 2014. ADDITIONAL REPORTED SYMPTOMS INCLUDED FLU LIKE SYMPTOMS, SWELLING AND INCREASED SPASTICITY. THE PATIENT¿S HUSBAND DESCRIBED IT AS ¿IT WAS LIKE SHE WAS WITHDRAWING FROM HEROIN¿. THE SURGEON SUGGESTED THAT THEY WERE UNABLE TO ASPIRATE THE CATHETER AT HER REPLACEMENT SURGERY. UPON THE CATHETER REPLACEMENT ON (B)(6) 2014, THE OLD CATHETER WAS REMOVED AND REPLACED WITH A NEW CATHETER. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED. PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE WITH NO INJURY. THE DEVICE SYSTEM DELIVERED BACLOFEN. IT WAS LATER REPORTED THAT THE PRODUCT ISSUE WAS CONSIDERED RESOLVED FOLLOWING THE CATHETER REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306333 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention