BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1872810 · Received October 14, 2010

    Report

    Report Number
    3007566237-2010-07944
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PUMP REPLACEMENT SURGERY, DUE TO THE NORMAL END OF LIFE (EOL) OF THE DEVICE, IT WAS OBSERVED THAT THE CONNECTOR ATTACHED TO THE PUMP WAS BROKEN, PROBABLY DUE TO THE PRESSURE CREATED BY THE SILK SUTURE. IT WAS IMPOSSIBLE TO CONNECT THE CATHETER IN A SAFE MANNER TO THE NEW PUMP. FOR THIS REASON, THE PATIENT'S PHYSICIAN DECIDED TO CUT THE CONNECTOR AND TWO CENTIMETERS OF THE PUMP SIDE CATHETER. THE CUT CATHETER WAS REPLACED WITH AN EQUIVALENT LENGTH OF A NEW CATHETER AND CONNECTOR. A NEW (B)(4) PUMP SIDE CATHETER WAS USED. THE REPLACED CATHETER WAS DISCARDED IN THE OPERATING ROOM. THERE WERE NO FURTHER MEDICAL COMPLICATIONS NOTED. BACLOFEN WAS USED IN THE PATIENT'S PUMP, BUT THERE WAS NO INFORMATION PROVIDED REGARDING THE CONCENTRATION OR DOSAGE OF THE PUMP MEDICATION. THERE WERE NO PATIENT-RELATED PROBLEMS AND THE PATIENT CONTINUED WITH THE THERAPY. NO FURTHER DETAILS, PATIENT SYMPTOMS OR OUTCOME WERE PROVIDED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE PROVIDED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8711, LOT #UNK