BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3162221 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10131
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    June 3, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER: PRODUCT ID 8784, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAS HAD MULTIPLE CATHETER REVISIONS (REFER TO MANUFACTURER REPORT # 3004209178-2013-07686 AND MANUFACTURER REPORT # 3004209178-2013-06556 FOR PREVIOUSLY REPORTED CATHETER REVISIONS) FOLLOWING A PUMP REPLACEMENT. THE HEALTH CARE PROVIDER (HCP) THEN DECIDED TO PLACE A NEW CATHETER INTO THE VENTRICLE BECAUSE HE FELT THAT POTENTIALLY SCARRING MIGHT BE PREVENTING CONTINUED SUCCESSFUL THERAPY INTO THE INTRATHECAL SPACE. THE EXISTING CATHETER WAS REPORTEDLY CAPPED/ABANDONED/PARTIALLY REMOVED HOWEVER IT WAS ALSO NOTED THE CATHETER WOULD NOT BE RETURNED BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THE HCP DECIDED TO DISCONTINUE THE INTRATHECAL PLACEMENT OF THE CATHETER. THE HCP BELIEVED THAT MULTIPLE CATHETER REVISIONS MIGHT HAVE CREATED EXCESSIVE SCARRING THAT MIGHT BE PREVENTING THE CATHETER FROM WORKING AND THEREFORE THE DECISION WAS MADE TO IMPLANT THE NEW CATHETER INTO THE VENTRICLE. THE SYMPTOMS THE PATIENT EXPERIENCED AS A RESULT OF THE EVENT INCLUDED INCREASED SPASTICITY AND LESS THAN FIFTY PERCENT THERAPY RELIEF. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD SOME TYPE OF CHEMICAL IN HIS SPINE THAT WAS BLOCKING THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262818 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention