BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3872806 · Received June 13, 2014

    Report

    Report Number
    3007566237-2014-01645
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8596, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER, SERIAL NUMBER (B)(4), FOUND CATHETER BODY HOLE (OR TORN CATHETER) CAUSED BY METAL PIN OF PUMP CONNECTOR POKING.

    Additional Manufacturer Narrative · 1

    (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

    IT WAS REPORTED THAT AT A PUMP REPLACEMENT SURGERY DUE TO EXPECTED END OF LIFE (EOL), WHEN THE HEALTHCARE PROVIDER (HCP) DISCONNECTED EXISTING IMPLANTED CATHETER FROM PUMP THERE WAS NO RETROGRADE FLOW CSF OBTAINED. IT WAS NOTED THAT THE EXISTING CATHETER WAS EXPLANTED AND REPLACED. IT WAS REPORTED THAT AFTER CONSULTING WITH THE MANAGING HCP THE INFUSION RATE WAS DECREASED TO 350 MCG/DAY FROM 700 MCG/DAY. IT WAS NOTED THAT THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR A 23 HOUR STAY FOR OBSERVATION. IT WAS REPORTED THAT THE ACTIONS REQUIRED AS A RESULT OF THE EVENT INCLUDED HOSPITALIZATION, REPLACEMENT AND REPROGRAMMING. IT WAS NOTED THAT THE CAUSE OF THE PRODUCT ISSUE WAS UNKNOWN. IT WAS REPORTED THAT THE MANAGING HCP HAD REPORTED THE PATIENT WAS RECEIVING EFFECTIVE THERAPY PRIOR TO SURGERY AND HAD NO REASON TO BELIEVE SYSTEM WAS NOT WORKING. IT WAS NOTED THAT THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS ALIVE ¿ NO INJURY. IT WAS REPORTED THAT THERE WERE NO PATIENT SYMPTOMS. IT WAS REPORTED THAT THE PUMP WAS USED TO INFUSE GABLOFEN. IT WAS REPORTED SEVEN DAYS LATER THE CATHETER ISSUE WAS NOT DETERMINED. IT WAS NOTED THAT THE ROOT CAUSE OF THE INABILITY TO OBTAIN RETROGRADE FLOW WAS NOT DETERMINED. IT WAS REPORTED THAT THE LOCATION THE ISSUE WAS IDENTIFIED WAS WHEN THE NEUROSURGEON DISCONNECTED THE SUTURELESS CONNECTOR FROM THE PUMP AND THERE WAS NO RETROGRADE FLOW OF CSF. IT WAS NOTED THAT THERE WAS NEVER A DETERMINATION ON WHERE THE ISSUE WAS LOCATED. IT WAS REPORTED THAT THERE WAS NEITHER ANY FURTHER TROUBLESHOOTING DONE NOR WAS ANY FURTHER ACTION TAKEN. IT WAS NOTED THAT THE PATIENT IS CURRENTLY DOING WELL AND RECEIVING THERAPEUTIC AFFECT PER THE CLINICIAN. IT WAS LATER REPORTED THAT THE PUMP WAS USED TO INFUSE MORPHINE. IT WAS NOTED THAT THERE WERE NO SYMPTOMS, THE HEALTHCARE PROVIDER (HCP) WANTED PUMP REPLACED DUE TO AGE OF ORIGINAL PUMP. IT WAS REPORTED THAT THE HCP TORE THE SUTURELESS CONNECTOR OFF THE PUMP AND THE INNER METAL BROKE AWAY FROM THE OUTER SILICONE. IT WAS NOTED THAT THERE WERE NO TROUBLESHOOTING EXCEPT TO INTRODUCE OPTION OF REPLACING CATHETER. IT WAS REPORTED THAT THE PATIENT WAS HEALING AND GETTING THERAPEUTIC TREATMENT FROM NEW PUMP. IT WAS REPORTED THAT THE PATIENT WAS SEEN ON (B)(6) 2014 IN CLINIC AND WAS RECEIVING GOOD THERAPY WITH NO PROBLEMS. IT WAS NOTED THAT THE PUMP REPLACEMENT WAS ON (B)(6) AND DURING THAT PROCEDURE WAS WHEN THE CALL WAS MADE TO TECH SUPPORT. IT WAS REPORTED THAT THE PUMP CONNECTOR WAS BROKEN WHILE BEING PLACED ON THE PUMP. IT WAS NOTED THAT ANOTHER CONNECTOR WAS OBTAINED AND USED. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY ACCORDING TO THE CLINIC. IT WAS REPORTED THAT THE PUMP WAS EXPLANTED DUE TO EXPECTED EOL ONLY.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED ONLY THE EVENT ASSOCIATED WITH NO RETROGRADE CATHETER FLOW IDENTIFIED DURING A PUMP REPLACEMENT SURGERY PERTAINS TO THIS MANUFACTURER'S REPORT. ALL OTHER INFORMATION INVOLVING THE EVENT IN WHICH A CONNECTOR WAS BROKEN WHILE BEING PLACED ON A PUMP PERTAINS TO MANUFACTURER'S REPORT # 3004209178-2014-09286. THE FOLLOWING INFORMATION NO LONGER APPLIES TO THIS MANUFACTURE'S REPORT, [IT WAS LATER REPORTED THAT THE PUMP WAS USED TO INFUSE MORPHINE. IT WAS NOTED THAT THERE WERE NO SYMPTOMS, THE HEALTHCARE PROVIDER (HCP) WANTED PUMP REPLACED DUE TO AGE OF ORIGINAL PUMP. IT WAS REPORTED THAT THE HCP TORE THE SUTURELESS CONNECTOR OFF THE PUMP AND THE INNER METAL BROKE AWAY FROM THE OUTER SILICONE. IT WAS NOTED THAT THERE WERE NO TROUBLE SHOOTING EXCEPT TO INTRODUCE OPTION OF REPLACING CATHETER. IT WAS REPORTED THAT THE PATIENT WAS HEALING AND GETTING THERAPEUTIC TREATMENT FROM NEW PUMP. IT WAS REPORTED THAT THE PATIENT WAS SEEN ON (B)(6) 2014 IN CLINIC AND WAS RECEIVING GOOD THERAPY WITH NO PROBLEMS. IT WAS NOTED THAT THE PUMP REPLACEMENT WAS ON (B)(6) AND DURING THAT PROCEDURE WAS WHEN THE CALL WAS MADE TO TECH SUPPORT. IT WAS REPORTED THAT THE PUMP CONNECTOR WAS BROKEN WHILE BEING PLACED ON THE PUMP. IT WAS NOTED THAT ANOTHER CONNECTOR WAS OBTAINED AND USED. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY ACCORDING TO THE CLINIC.], PLEASE REFER TO MANUFACTURER'S REPORT # 3004209178-2014-09286 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350187 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization