BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2895411 · Received January 3, 2013

    Report

    Report Number
    3007566237-2013-00027
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 5, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER (MODEL 8709SC SERIAL # (B)(4)) FOUND NO SIGNIFICANT ANOMALY. NON-SIGNIFICANT INDENT IN SEAL WAS FOUND IN THE SUTURELESS CONNECTOR THOUGH IT DID NOT AFFECT INFUSION. THERE WAS NOT ENOUGH OF THE INDENT LOCATION IN THE SILICONE SEAL DOWN IN THE SUTURELESS CONNECTOR CUP AND THEREFORE, IT DID NOT MEET THE CRITERIA FOR OCCLUSION. FINAL ANALYSIS ALSO FOUND NO STRAIN RELIEF SHROUD FOR THE DISTAL SIDE OF THE PIN CONNECTOR WAS RETURNED AND THE DISTAL PORTION HAD A 46 CM HASH MARK ON IT. THIS DID NOT MATCH UP TO ANY OF THE OTHER SEGMENTS RETURNED AND IT WAS POSSIBLE THAT SIGNIFICANT PORTIONS OF THE IMPLANTED CATHETER WERE NOT RETURNED. BECAUSE OF THIS, NO CONCLUSION COULD BE MADE IN REGARDS TO THE ALLEGATION. ANALYSIS OF THE CATHETER (MODEL 8709SC SERIAL # (B)(4)) FOUND NO SIGNIFICANT ANOMALY. DRIED DRUG OR BLOOD OCCLUSION WAS FOUND IN THE CATHETER BODY. INITIALLY THERE WAS AN OCCLUSION NOTICED IN ONE OF THE SEGMENTS RETURNED DURING THE DECONTAMINATION PROCEDURE, BUT THE OCCLUSION WAS BROKEN LOOSE. PRESSURE TESTING DID NOT SHOW ANY HOLES IN THE CATHETER. THE PROXIMAL END OF ONE OF THE SEGMENT WAS NOT SMOOTH AND HAD OBSERVED CHARACTERISTICS THAT INDICATED THE CATHETER WAS TORN AT THAT POINT, INCLUDING THE FACT THE CROSS SECTIONAL VIEW OF THIS END WAS SOMEWHAT CIRCULAR IN SHAPE. THIS INDICATED NO COMPRESSION OCCURRED. IT WAS NOTED THAT MANY OF THE SEGMENTS RETURNED DID NOT MATCH UP. THIS INDICATED THAT CERTAIN PORTIONS OF THE IMPLANTED CATHETER WERE NOT RETURNED FOR ANALYSIS. BECAUSE OF THE MISSING SEGMENTS OF THE CATHETER, NO DEFINITIVE CONCLUSION COULD BE MADE IN REGARDS TO THE ALLEGATION OF OCCLUSION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: CATHETER: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE LACK OF EFFECTIVENESS WAS DUE TO A CATHETER OCCLUSION. THE OCCLUSION WAS DETERMINED VIA A CATHETER DYE STUDY. A CATHETER REVISION WAS PERFORMED. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND WAS WITHOUT INJURY.

    Description of Event or Problem · 1

    AN UNKNOWN CATHETER ISSUE WAS REPORTED. A DYE STUDY WAS PERFORMED, BUT THE PHYSICIAN WAS UNABLE TO ASPIRATE. THE PHYSICIAN STATED THAT "HE WOULD SEND THE PATIENT FOR A CATHETER REVISION." THE PATIENT EXPERIENCED A LACK OF EFFICACY AND AN INCREASE IN SPASTICITY. THE PATIENT WAS NOTED TO BE ALIVE, BUT WITH INJURY AS OF THE DATE OF THIS REPORT. THE MEDICATION USED WITHIN THE SYSTEM WAS LIORESAL. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2376 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention