BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 9940922 · Received April 8, 2020

    Report

    Report Number
    2182207-2020-00121
    Event Type
    Injury
    Date Received
    April 8, 2020
    Date of Event
    January 2, 2020
    Report Date
    April 8, 2020
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SKALSKY A.J., DALAL P., LE J., EWING E., YASZAY B. 2020. SCREENING INTRATHECAL BACLOFEN PUMP SYSTEMS FOR CATHETER PATENCY VIA CATHETER ACCESS PORT ASPIRATION. NEUROMODULATION 2020; E-PUB AHEAD OF PRINT. DOI:10.1111/NER.13106. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE ACCEPTANCE FOR PUBLICATION AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. PER FDA DRAFT GUIDANCE JULY 9 2013 THESE EVENTS ARE REPORTED ON ONE MDR DUE TO NO PATIENT IDENTIFIER. CONTINUATION OF CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-40, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: 8780, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-20, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: 8780, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-40, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: 8780, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-40, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: 8780, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-40, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: 8780, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-20, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: 8780, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-20, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: 8780, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-20, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: 8780, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-40, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: 8780, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-40, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: 8780, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-40, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: 8780, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-20, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: 8784, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-20, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: 8709, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8637-40, SERIAL#: UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: 8784, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: 8780, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8637-40, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8780, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8637-20, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8780, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8637-40, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8780, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8637-40, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8780, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8637-40, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8780, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8637-20, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8780, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8637-20, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8780, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8637-20, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8780, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8637-40, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8780, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8637-40, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8780, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8637-40, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8780, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8637-20, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8784, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8637-20, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8709, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8637-40, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 8784, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    SUMMARY: CATHETER PATENCY WAS EXAMINED BY PERFORMING A CATHETER ACCESS PORT STUDY IN 91 PEDIATRIC AND ADULT PATIENTS UNDERGOING ITB THERAPY. DESPITE NO PREOPERATIVE CLINICAL SUSPICION OF A PROBLEM WITH THE ITB SYSTEM IN ALL BUT ONE CASE, 16.5% OF THE CATHETERS IN OUR PATIENT POPULATION WERE NOT PATENT. REPORTED EVENTS: 1. (PLI 10 & 20) A REPORT OF A NON-PATENT CATHETER IMPLANTED FOR 60.4 MONTHS USED TO INFUSE GABLOFEN (2000MCG/ML AT 955MCG/DAY) THAT WAS FOUND TO BE BROKEN. THE CATHETER WAS REPLACED. 2. (PLI 30 & 40) A REPORT OF A NON-PATENT CATHETER IMPLANTED FOR 16.2 MONTHS USED TO INFUSE GABLOFEN (2000MCG/ML AT 543MCG/DAY) THAT WAS FOUND TO BE OCCLUDED BETWEEN THE SPINAL SEGMENT AND THE PUMP. THE CATHETER WAS REPLACED. 3. (PLI 50 & 60) A REPORT OF A NON-PATENT CATHETER IMPLANTED FOR 61.2 MONTHS USED TO INFUSE GABLOFEN (2000MCG/ML AT 725MCG/DAY) WITH NO IDENTIFIED ETIOLOGY. THE CATHETER WAS REPLACED. 4. (PLI 70 & 80) A REPORT OF A NON-PATENT CATHETER IMPLANTED FOR 34.7 MONTHS USED TO INFUSE GABLOFEN (2000MCG/ML AT 1739MCG/DAY)WITH NO IDENTIFIED ETIOLOGY. THE CATHETER WAS REPLACED. 5. (PLI 90 & 100) A REPORT OF A NON-PATENT CATHETER IMPLANTED FOR 39.5 MONTHS USED TO INFUSE GABLOFEN (2000MCG/ML AT 636MCG/DAY) WITH NO IDENTIFIED ETIOLOGY. THE CATHETER WAS REPLACED. 6. (PLI 110 & 120) A REPORT OF A NON-PATENT CATHETER IMPLANTED FOR 17.9 MONTHS USED TO INFUSE GABLOFEN (1000MCG/ML AT 315MCG/DAY) THAT WAS FOUND TO BE BROKEN. THE CATHETER WAS REMOVED. 7. (PLI 130 & 140) A REPORT OF A NON-PATENT CATHETER IMPLANTED FOR 6.9 MONTHS USED TO INFUSE GABLOFEN (2000MCG/ML AT 510MCG/DAY) WITH NO IDENTIFIED ETIOLOGY. THE CATHETER WAS REPLACED. 8. (PLI 150 & 160) A REPORT OF A NON-PATENT CATHETER IMPLANTED FOR 84.8 MONTHS USED TO INFUSE GABLOFEN (2000MCG/ML AT 179MCG/DAY) THAT WAS FOUND TO BE BROKEN. THE CATHETER WAS REPLACED. 9. (PLI 170 & 180) A REPORT OF A NON-PATENT CATHETER IMPLANTED FOR 68.8 MONTHS USED TO INFUSE GABLOFEN (2000MCG/ML 1388MCG/DAY) WITH NO IDENTIFIED ETIOLOGY. THE CATHETER WAS REPLACED. 10. (PLI 190 & 200) A REPORT OF A NON-PATENT CATHETER IMPLANTED FOR 46.3 MONTHS USED TO INFUSE GABLOFEN (2000MCG/ML AT 1856MCG/DAY) WITH NO IDENTIFIED ETIOLOGY. THE CATHETER WAS REMOVED. 11. (PLI 210 & 220) A REPORT OF A NON-PATENT CATHETER IMPLANTED FOR 82.2 MONTHS USED TO INFUSE GABLOFEN (2000MCG/ML AT 457MCG/DAY) WITH NO IDENTIFIED ETIOLOGY. THE CATHETER WAS REPLACED. 12. (PLI 230 & 240) A REPORT OF A NON-PATENT CATHETER IMPLANTED FOR 54.2 MONTHS USED TO INFUSE GABLOFEN (2000MCG/ML AT 670MCG/DAY) THAT WAS FOUND TO BE BROKEN. THE CATHETER WAS REPLACED. 13. (PLI 250 & 260) A REPORT OF A NON-PATENT CATHETER IMPLANTED FOR 84.4 MONTHS USED TO INFUSE GABLOFEN (2000MCG/ML AT 837MCG/DAY) THAT WAS FOUND TO BE BROKEN. THE CATHETER WAS REPLACED. 14. (PLI 270 & 280) A REPORT OF A NON-PATENT CATHETER IMPLANTED FOR 117.3 MONTHS USED TO INFUSE GABLOFEN (2000MCG/ML AT 490MCG/DAY) THAT WAS FOUND TO BE BROKEN IN THE SPINAL SEGMENT. THE CATHETER WAS REPLACED, BUT IT WAS NOTED THAT A PORTION OF THIS CATHETER COULD NOT BE REMOVED. 15. (PLI 290 & 300) A REPORT OF A NON-PATENT CATHETER IMPLANTED FOR 116.3 MONTHS USED TO INFUSE GABLOFEN (2000MCG/ML AT 931MCG/DAY) THAT WAS FOUND TO BE TAUGHT AND KINKED. THE CATHETER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397970 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC INC. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention