BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2161979 · Received July 11, 2011

    Report

    Report Number
    6000030-2011-05324
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 20, 2011
    Report Date
    March 22, 2017
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: CONCLUSION CODE NO LONGER APPLICABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A MICRO-TEAR APPROX THREE INCHES FROM THE PUMP CONNECTOR. THERE WAS A CHALKY BUILDUP AROUND THE SITE OF THE MICRO-TEAR. THE PT'S DOSAGE OF MEDICATION HAD BEEN ADJUSTED REPEATEDLY, BUT THE PT DID NOT RESPOND. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PATIENT HAD A CRACKED CATHETER REVISED 6 MONTHS PRIOR TO THE PUMP'S EOS. THE PATIENT BELIEVED THEY HAD A CYST WHERE THE CATHETER WAS AND WHEN THEY OPENED UP THE PATIENT THEY FOUND A CRACK ON THE CATHETER. THE PATIENT ALSO REPORTED THAT WHEN HER LAST PUMP "DIED", IT JUMPED SIDEWAYS ON THE DAY IT DIED. THE PATIENT FURTHER REPORTED THAT WHEN THEIR OLD ALARM WOULD GO OFF, WHEN IT WAS LOW, IT WOULD GET LOUDER, LOUDER AND LOUDER AND THEY WOULD HEAR IT IMMEDIATELY AND HER OLD PUMP "VIBRATED" WHEN IT WENT OFF. THE PUMP DELIVERED HYDROMORPHONE, CLONIDINE, AND BUPIVACAINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS TOLD THEY HAD A LEAK IN THE CATHETER. THE PATIENT ALSO STATED THAT THEY WERE ON MORPHINE WITH THEIR PUMP. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    FOLLOWING THE PATIENT'S NON-RESPONSE TO PUMP MEDICATION ADJUSTMENTS, A CATHETER STUDY WAS PERFORMED DURING A CATHETER REVISION ON (B)(6) 2011. AT THAT TIME, THE PREVIOUSLY REPORTED CATHETER MICRO-TEAR WAS DISCOVERED. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT'S PUMP HAD BEEN "FIXED" BECAUSE IT WAS "CRACKED" AND PUMP MEDICATION HAD LEAKED OUT. NO INFORMATION WAS PROVIDED REGARDING THE TYPE, CONCENTRATION OR DOSAGE OF MEDICATION USED IN THE PUMP. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention IMPLANTED:| EXPLANTED: