BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3210530 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-11442
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    June 14, 2013
    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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    CONCOMITANT PRODUCTS: CATHETER MODEL: 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013; CATHETER MODEL: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013; CATHETER MODEL: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE MODEL 8596SC PORTION OF SEGMENT 1 FOUND NO SIGNIFICANT ANOMALIES WITH THE RETURNED SEGMENT. IT PASSED PATENCY AND PRESSURE TESTING. ANALYSIS OF THE MODEL 8731SC PORTION OF SEGMENTS 1 AND 2 ALSO FOUND NO SIGNIFICANT ANOMALIES WITH EITHER RETURNED SEGMENT. BOTH PASSED PATENCY AND PRESSURE TESTING. OF MINOR NOTE WAS A SLIGHTLY COMPRESSED AREA ON THE DISTAL PORTION OF THE 8731 SC BETWEEN THE 18 AND 19 CM MARKINGS. IT WAS UNCERTAIN IF THIS AREA WAS COMPRESSED ENOUGH TO CAUSE AN OCCLUSION. ANALYSIS OF THE MODEL 8709 PORTIONS OF SEGMENTS 1 AND 2 ALSO FOUND NO SIGNIFICANT ANOMALIES WITH EITHER RETURNED SEGMENT. BOTH PASSED PATENCY AND PRESSURE TESTING. REMOVED CONCLUSION CODE 54 AS IT NO LONGER APPLIES.

    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: A MICROFRACTURE WAS SUSPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD RETURN OF SYMPTOMS OVER SEVERAL MONTHS ESPECIALLY INCREASED SPASTICITY. X-RAYS WERE NORMAL AND PER REPORTER AN INDIUM TEST WAS ALSO DONE, HOWEVER RESULTS WERE UNKNOWN. IT WAS STATED THAT THE CATHETER (MODEL 8596SC) WAS REPLACED DUE TO KINK AND OCCLUSION IN THE PROXIMAL SEGMENT AT THE PUMP CONNECTOR. IT WAS ALSO STATED THAT PATIENT HAD HAD PREVIOUS REVISIONS WHICH WERE INDICATED ON THE PROGRAMMER; MULTIPLE SPLICES WERE SEEN IN THE OLD CATHETERS (MODEL 8709 AND 8731SC) DURING REPLACEMENT, REPORTED CAUSE WAS ¿CATHETER MALFUNCTION UNKNOWN¿. THE ENTIRE OLD CATHETER REMOVED AND REPLACED ON (B)(6) 2013. FOLLOWING WHICH THE DRUG DOSE WAS DECREASED TO 100MCG/DAY; DRUG DELIVERED VIA THE DEVICE WAS GABLOFEN. PATIENT WAS INDICATED TO HAVE BEEN HOSPITALIZED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310171 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R