BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3994157 · Received August 8, 2014

    Report

    Report Number
    3007566237-2014-02220
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8598A, LOT# SERIAL# (B)(4) IMPLANTED: (B)(4) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: 2011, EXPLANTED: (B)(4) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. (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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE 8598A WAS NOT REQUIRED AS IT WASN¿T RETURNED. ANALYSIS OF THE 8709SC CATHETER FOUND NO SIGNIFICANT ANOMALY; THE SC CONNECTOR HAD A NON-SIGNIFICANT IN THE SEAL THAT DIDN¿T AFFECT INFUSION. ANALYSIS OF THE UNKNOWN CATHETER FOUND NO SIGNIFICANT ANOMALY; IT WAS INCOMPLETE/ RETURNED IN SEGMENTS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER KINK IN THE DISTAL SEGMENT OCCURRED. PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT INCLUDED UNDERDOSE SYMPTOMS. THE PATIENT HAD STATED SHE WAS NOT GETTING EFFECTIVE THERAPY AND WAS CONVINCED THE PUMP OR CATHETER WAS NOT WORKING. THE PUMP WAS WORKING FINE. IT WAS UNKNOWN IF ANY DIAGNOSTIC TESTING OR TROUBLESHOOTING HAD BEEN PERFORMED. IT WAS THEN REPORTED HOWEVER THAT THE RADIOLOGIST WHO DID THE TROUBLESHOOTING THOUGHT THERE WAS A KINK AROUND L5 OF THE PATIENT¿S SPINE IN THE DISTAL SEGMENT BUT THE REPLACING SURGEON DID NOT THINK ANY PART OF THE CATHETER LOOKED KINKED. WHEN HE CUT A PIECE OF THE DISTAL SEGMENT, THERE WAS GOOD FLOW. THE CATHETER WAS REPLACED WITH AN ASCENDA 8781 AND THE DOSE WAS NEARLY UNCHANGED AT 507MCG/DAY. THE PATIENT WAS GOING TO BE DISCHARGED WITHIN A FEW HOURS AFTER THE SURGERY IT WAS REPORTED. THE OLD CATHETER WAS TO BE RETURNED FOR ANALYSIS. ACTIONS REQUIRED AS A RESULT OF THE EVENT CONSISTED OF THE REPLACEMENT. IT WAS REPORTED THE 8598A AND 8709SC WERE BOTH EXPLANTED. THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS LISTED AS ¿ALIVE ¿ NO INJURY¿. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN. IT WAS ALSO REPORTED BACLOFEN UNDERDOSE OCCURRED. THERE WAS NO PATIENT INJURY. PER THE RETURN PAPERWORK, THE REASON FOR REMOVAL WAS THAT THERAPY WAS SUB THERAPEUTIC AND THAT THERE WAS A POSSIBLE KINK. UPON RECEIVING THE PRODUCT, IT WAS NOTED THE 8598 WASN¿T RECEIVED BUT THE 8709SC AND AN UNKNOWN CATHETER WERE. IT WAS FURTHER REPORTED EXACT SYMPTOMS INCLUDED INCREASED TONE AND IT WAS REPORTED THE PATIENT THOUGHT THERE WAS A CATHETER KINK. ¿ABOUT TWO WEEKS AGO,¿ IN REFERENCE TO (B)(6) 2014, THE PATIENT WENT IN FOR DIAGNOSTIC TROUBLESHOOTING WITH RADIOLOGY. THE RADIOLOGIST AT THAT TIME THOUGHT THERE COULD BE A KINK IN THE DISTAL SEGMENT. WHEN THE CATHETER WAS REPLACED THE HEALTH CARE PROVIDER (HCP) COULDN¿T FIND ANYTHING WRONG WITH THE CATHETER AND THERE WAS GOOD FLOW. THE HCP STATED THAT THE OTHER REVISIONS THAT WERE DONE IN YEARS PAST ALSO HAD CATHETERS THAT HAD GOOD FLOW. (REFER TO MANUFACTURER REPORT #¿S 3007566237-2011-08979, 3007566237-2010-10749, 3007566237-2010-03454 AND 3007566237-2010-01185 FOR THE PATIENT¿S PRIOR CATHETER REVISIONS). THE ONLY ADDITIONAL ACTION THAT WAS TAKEN WAS A COMPLETE REPLACEMENT OF THE CATHETER AS PREVIOUSLY Y REPORTED. THE PATIENT WAS DOING FINE NOW AND WAS IN THE PROCESS OF BEING TITRATED BACK TO EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467197 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R