BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3705787 · Received March 27, 2014

    Report

    Report Number
    3007566237-2014-00841
    Event Type
    Injury
    Date Received
    March 27, 2014
    Report Date
    March 5, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE CATHETER, PRODUCT ID 8 590-1, LOT# N231081, IMPLANTED: 2010-(B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY. ANALYSIS OF THE CATHETER REVEALED CATHETER BODY DAMAGE, OCCURRED TO CATHETER BODY AND/OR GUIDEWIRE DURING IMPLANT PROCEDURE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. (B)(4).

    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 THE LAST REFILL ON (B)(6) 2014 THERE WAS A LARGE DISCREPANCY. THERE WAS MORE DRUG THAN WAS EXPECTED; EXACT VOLUMES WERE NOT PROVIDED. ON (B)(6) 2014, A DYE STUDY WAS ATTEMPTED AND THE PHYSICIAN WAS UNABLE TO ASPIRATE FROM THE CAP (CATHETER ACCESS PORT). IMAGING WAS DONE AND THERE WERE SOME POSSIBLE KINKS SEEN, BUT IT WAS UNKNOWN FOR CERTAIN. THE EVENT LOGS WERE PULLED AND THERE WAS A MOTOR STALL AND RECOVERY FOR 1 HOUR ON (B)(6) 2013, ANOTHER STALL/RECOVERY FOR 2 HOURS ON (B)(6) 2013, AND THEN ANOTHER STALL/RECOVERY FOR 1 HOUR ON (B)(6) 2013. THE PATIENT DID NOT RECALL HAVING AN MRI (MAGNETIC RESONANCE IMAGING), ONLY THAT HE WENT TO A BASKETBALL GAME. THE PATIENT WAS BEING SCHEDULED FOR A CATHETER REVISION AND A POSSIBLE PUMP REPLACEMENT IN THE FUTURE. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL, BUPIVACAINE AND PRIALT. IT WAS LATER REPORTED THAT THE PATIENT HAD A REFILL ON (B)(6) 2014 WITH 1.5CC EXPECTED IN THE RESERVOIR AND 5CC ASPIRATED. THE PREVIOUS 2 REFILLS HAD 2CC EXTRA. THE PATIENT VERBALIZED HAVING INCREASED PAIN SYMPTOMS AND NEEDED TO TAKE MORE MEDICATION ORALLY. NO KINKS WERE EVIDENT; HOWEVER, THE PHYSICIAN WAS UNABLETO ASPIRATE THE CATHETER FOR THE DYE STUDY. THE PLAN WAS TO REVISE/REPLACE THE CATHETER, BUT SINCE MOTOR STALLS WERE NOTED IN THE LOGS THE PHYSICIAN WILL BE SCHEDULING A TOTAL REPLACEMENT OF THE PUMP AND CATHETER. NO DATE HAS BEEN SET. THE PATIENT DID NOT HAVE ANY MRI AROUND THE TIME OF THE MOTOR STALLS AND NO OTHER MAGNETIC POSSIBILITIES WERE EVIDENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE PATIENT RECEIVING EFFECTIVE THERAPY NOW. ADDITIONAL INFORMATION LATER REPORTED CRYSTALLIZATION FOUND AT TIP AND ALONG CATHETER (POSSIBLE TEAR). A ROTOR STUDY WAS PERFORMED AND LOOKED NORMAL. THE PUMP AND CATHETER WERE EXPLANTED (B)(6)-2014. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180084 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention