BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2863742 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11358
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 9, 2012
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INTERMITTENT THERAPY. IT WAS INDICATED THAT THE PUMP WOULD DELIVER EITHER TOO MUCH OR NOT ENOUGH MEDICATION. IT WAS STATED THAT THE PUMP HAD GIVEN THE PATIENT A BOLUS ALTHOUGH IT WAS NOT PROGRAMMED TO DO SO. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR PUMP SURGERY, HOWEVER IT WAS REPORTED THAT THERE WAS NOTHING WRONG WITH THE PUMP. MULTIPLE TROUBLE-SHOOTING INDICATED THAT THERE WAS NOTHING WRONG WITH THE PUMP, INCLUDING PUMP INTERROGATION AND PUMP LOGS THAT WERE CHECKED. THERE WAS NO PATIENT SYMPTOMS REPORTED. IT WAS LATER REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY BACLOFEN RELATED SYMPTOMS (OVERDOSE OR UNDERDOSE) ACCORDING TO PHYSICIAN. THE DYE STUDY WAS PERFORMED (B)(6) 2012 AND BOTH CATHETER AND PUMP SHOWED NO PROBLEMS. ALL RESIDUAL VOLUMES HAD BEEN ACCURATE. COMPLETE REPLACEMENT OF THE SYSTEM WAS DONE (B)(6) 2012. THE OUTCOME OF THE PATIENT WAS REPORTED AS STILL IN-PATIENT AT THE HOSPITAL WITH NO CHANGE IN STATUS. THE DRUGS DELIVERED VIA PUMP WERE DILAUDID AND BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R