BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4092925 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17090
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER; PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY; PRODUCT ID 8711, LOT# J11459R22, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER; PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY; PRODUCT ID 8711, LOT# J11459R22, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S)-CORRECTED CATHETER INFORMATION TO INCLUDE EXPLANT DATES FOR PREVIOUS CATHETERS, AND TO INCLUDE INFORMATION FOR NEW CATHETER: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8711, LOT# J11459R22, IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6)2014, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP, MODEL # 8637-20, SN (B)(4), FOUND NO ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED A FLIPPED PUMP WAS CONFIRMED. THE PATIENT HAD BEEN SCHEDULED FOR A CATHETER DYE STUDY BUT THEY WERE UNABLE TO COMPLETE THE STUDY BECAUSE THE PUMP WAS FLIPPED. PATIENT SYMPTOMS INCLUDED LESS THAN 50 PERCENT THERAPY RELIEF. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WERE PERFORMED BUT WOULD BE IN THE FUTURE. THE PATIENT WAS REFERRED FOR A PUMP POCKET REVISION/REPLACEMENT THAT WAS SCHEDULED FOR (B)(6) 2014. THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS LISTED AS ¿ALIVE ¿ NO INJURY¿. THE DEVICE SYSTEM DELIVERED MORPHINE, BUPIVACAINE AND CLONIDINE. FURTHER DETAILS INCLUDING THE OUTCOME OF THE EVENT WERE NOT PROVIDED. ADDITIONAL INFORMATION FOLLOWING THE DATE OF THE REPLACEMENT/REVISION WILL BE ATTEMPTED TO BE OBTAINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE PATIENT'S LACK OF THERAPEUTIC EFFECT SINCE IMPLANT WAS THAT THE PUMP HAD FLIPPED SEVERAL TIMES, AND CAUSED KINKING/OCCLUSION OF THE PROXIMAL CATHETER SEGMENT. IT WAS NOTED THAT THE DYE STUDY WAS ABNORMAL. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT; HOWEVER, SHORTLY AFTER THE PATIENT'S CATHETER REPLACEMENT ON 2(B)(6) 014, THE PATIENT'S PAIN CAME BACK. DURING A PUMP REFILL ON (B)(6) 2014, THERE WAS A VOLUME DISCREPANCY WHERE THE ACTUAL RESIDUAL VOLUME (ARV) OF 7, WAS MORE THAN THE EXPECTED RESIDUAL VOLUME (ERV) OF 2 (THIS WAS ALSO REPORTED AS: ARV 7.2CC, ERV 2.8CC.) THE PATIENT HAD COMPLAINED OF PAIN, AND THAT "SOMETIMES IT WORKS SOMETIMES IT DOESN'TﻠAND HE THOUGHT THIS HAD BEEN ONGOING SINCE THE PUMP REPLACEMENT ON (B)(6) 2014. A ROTOR STUDY AND DYE STUDY WERE PERFORMED, WHICH SHOWED NO PROBLEMS WITH THE PUMP OR CATHETER. THE LAST DYE STUDY WAS PERFORMED ON (B)(6) 2014, WHICH WAS NORMAL, BUT THE HEALTHCARE PROVIDER (HCP) REPORTEDLY THOUGHT THE PUMP MIGHT BE A DEFECTIVE PUMP. THE PATIENT CLINICALLY WENT THROUGH FREQUENT EPISODES OF WITHDRAWAL AND INCREASED PAIN, CONSISTENT WITH THE PUMP WORKING INTERM INTTENTLY INSTEAD OF CONSISTENTLY. THE HCP SUSPECTED THE PUMP WAS DEFECTIVE, AND IN ADDITION, THE PATIENT HEARD THE PUMP ALARM LAST WEEK. THE PUMP WAS REPLACED ON (B)(6) 2014. THE PUMP SYSTEM WAS BEING USED TO INFUSE MORPHINE, BUPIVACAINE, AND CLONIDINE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S CATHETER WAS REPLACED AND THE PUMP WAS ORIENTED IN THE CORRECT POSITION IN THE POCKET ON (B)(6) 2014. (NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT).

    Description of Event or Problem · 1

    NO OUTCOME WAS REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL LATER REPORTED THAT THE PATIENT¿S SYMPTOMS RESOLVED AFTER THE REPLACEMENT SURGERY. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572640 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention