BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3061788 · Received April 16, 2013

    Report

    Report Number
    3004209178-2013-06367
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 19, 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

    ANALYSIS OF THE CATHETER REVEALED NO SIGNIFICANT ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CATHETER MODEL 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PROGRAMMER MODEL 8835 SERIAL # (B)(4); CATHETER MODEL 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012. (B)(4).

    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 THE PATIENT WAS DOING WELL. THE HEALTH CARE PROVIDER REPORTEDLY DID NOT FIND THE SOURCE OF THE HYGROMA SO HE OPTED TO REPLACE THE SPINAL SEGMENT OF THE CATHETER AND HAD NOT RETURNED IT SINCE. IT WAS LATER REPORTED NO DYE STUDY WAS DONE PER THE HEALTH CARE PROVIDER (HCP). THE HCP DID NOT SEND ANYTHING FOR CULTURE. THE HCP REPLACED THE SPINAL SEGMENT IN HOPES IT WOULD NOT RETURN BUT DID NOT SEE ANY REASON OR PLACE WHERE IT MAY HAVE BEEN LEAKING. IT WAS REPORTED ¿AND THEN THE PATIENT WAS STILL GETTING PAIN RELIEF DESPITE HYGROMA MID BACK¿. THE PATIENT REPORTEDLY DID NOT HAVE ANY COMPLAINS OF A RETURN HYGROMA SINCE THE CATHETER REPLACEMENT. THE DEVICE SYSTEM WAS USED TO DELIVER INFUMORPH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS GETTING "GOOD RELIEF" BUT "NOT AS GREAT AS IT WAS." THE PATIENT HAD A RECURRENT SEROMA AT THE SPINAL SITE WHICH WAS BOTHERING HER. THE HEALTH CARE PROVIDER (HCP) "NURSED IT" FOR A WHILE AND IT "WENT DOWN" AND HAD DRAINED IT ONCE. THE SEROMA APPEARED TO CHANGE IN SIZE, AT TIMES IT WAS "GOOSE EGG SIZE," OTHER TIMES IT WAS SMALLER, BUT ALWAYS THERE. THE PATIENT WAS REAL THIN AND YOUNG. THE HCP QUESTIONED IF THERE WAS A NICK "OR SOMETHING" IN THE CATHETER. HE HAD DONE A REVISION WHEREIN HE DID A "PURSE STRAIN" (WHICH HAD NOT BEEN DONE IN THE INITIAL IMPLANT) AND TOOK A LOOK, THERE WAS NOTHING LEAKING THAT HE COULD SEE. IT WAS THOUGHT THAT "IT CLOSED OFF ON ITS OWN." HOWEVER, POST REVISION, THE SEROMA APPEARED AGAIN ON THE PATIENT"S WAY BACK HOME. ON THE DAY OF THE INITIAL REPORT THE HCP WAS GOING TO DO A DYE STUDY AND A REFILL IN THE OR. THE HCP WAS THINKING TO REPLACE THE SPINAL SEGMENT REGARDLESS BECAUSE THE SEROMA WAS BOTHERSOME FOR THE PATIENT AND SHE WAS "IN AND OUT OF THE OFFICE." THE HCP WAS THINKING PART OF THE FLUID WAS POSSIBLY SOME OF THE MEDICATION ALONG WITH SOME CEREBROSPINAL FLUID. THE DEVICE SYSTEM AS USED TO INFUSE MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162639 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention