BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5350344 · Received January 7, 2016

    Report

    Report Number
    3007566237-2016-00081
    Event Type
    Injury
    Date Received
    January 7, 2016
    Report Date
    February 16, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-3043-2011, Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    GALICA, R., HAYEK, S.M., VEIZI, E., LAWRENCE,M.M., KHALIL,A.A., MCEWAN, M. SUDDEN INTRATHECAL DRUG DELIVERY MALFUNCTION: A CASE SERIES (10304). NORTH AMERICAN NEUROMODULATION SOCIETY 19TH ANNUAL MEETING. 2015. SUMMARY: INTRATHECAL DRUG DELIVERY SYSTEMS (IDDS) HAVE PROVEN TO BE VALUABLE IN MANAGING REFRACTORY CHRONIC PAIN FOR OVER THREE DECADES. THESE DEVICES, TIME TESTED AND OVERALL RELIABLE, HAVE LATELY BEEN NOTED TO UNEXPECTEDLY CEASE INFUSING. TWELVE PATIENTS FROM ONE ACADEMIC CENTER WHOSE MEDTRONIC SYNCHROMED II PUMPS MALFUNCTIONED ARE DESCRIBED. REPORTED EVENTS: A TOTAL OF 144 PATIENTS (ALL IMPLANTED WITH SYNCHROMED II) WERE IDENTIFIED. OF THESE PATIENTS, 90 (62.5%) WERE FEMALE AND 54 (37.5%) WERE MALE. TWELVE CASES OF DEVICE FAILURE WERE IDENTIFIED AMONG THE POPULATION. THE TOTAL PREVALENCE OF DEVICE FAILURE AMONG THIS POPULATION IS 8.33%. THE INCIDENCE RATE OF IDDS FAILURE IS 0.037 DEVICE FAILURES PER PATIENT PER YEAR. A SIGNIFICANT DIFFERENCE WAS FOUND BETWEEN DURATION OF TREATMENT IN DEVICE FAILURE VERSUS NON-DEVICE FAILURE PATIENTS (P = 0.0021). MEDIAN TIME FROM IMPLANT TO DEVICE FAILURE WAS 48 ᱳ.62 MONTHS. AMONG PATIENTS WHOSE DEVICES DID NOT FAIL, MEDIAN TIME FROM IMPLANT TO LAST FOLLOW UP WAS 18.5 ±22.57 MONTHS. ALL OTHER DIFFERENCES WERE FOUND TO BE NON-SIGNIFICANT. DYSFUNCTION IN THE MOTOR GEAR TRAIN WAS FOUND AFTER DESTRUCTIVE ANALYSIS OF SEVERAL DEVICES IN THIS SERIES. SEE ATTACHED LITERATURE ARTICLE

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP). IT WAS REPORTED THERE WERE 13 CASES OF DEVICE FAILURE IDENTIFIED AMONG THE POPULATION. EIGHT OF THE 13 PATIENTS WHOSE DEVICES MALFUNCTIONED WERE BEING TREATED WITH A COMBINATION OF HYDROMORPHONE AND BUPIVACAINE AT THE TIME OF DEVICE FAILURE. OF THE 8 PATIENTS BEING TREATED WITH HYDROMORPHONE AND BUPIVACAINE, ONE WAS ALSO RECEIVING ZICONOTIDE. DEVICE FAILURE OCCURRED IN 3 PATIENTS BEING TREATED WITH A COMBINATION OF FENTANYL AND BUPIVACAINE AND 1 PATIENT RECEIVING MORPHINE AND BUPIVACAINE. LAST, MALFUNCTION OCCURRED IN A PATIENT WHOSE INFUSATE CONSISTED ONLY OF BACLOFEN. MEDIAN TIME FROM IMPLANT TO DEVICE FAILURE WAS 48 + 14.09 MONTHS. AS OF THE DATE OF THIS REPORT, 12 OF 13 EXPLANTED DEVICES HAD BEEN RECEIVED AND ANALYZED BY THE MANUFACTURER. IN CASES 1 THROUGH 3, 5, AND 6, DESTRUCTIVE ANALYSIS REPORTS PROVIDED BY THE MANUFACTURER REVEALED WEARING AND RESIDUE ON THE UPPER SHAFT OF GEAR NUMBER 2 IN THE MOTOR GEAR TRAIN, WHICH WAS THOUGHT TO HAVE CONTRIBUTED TO THE DEVICES' MOTOR STALLS. DESTRUCTIVE ANALYSIS OF CASE 4 REVEALED A GEAR TRAIN ANOMALY WITH CORROSION AS WELL AS A SMALL AMOUNT OF MOISTURE AND RESIDUE ON THE BOTTOM SIDE OF THE PUMP HEAD HOUSING. THE REASON IDENTIFIED FOR MOTOR STALL IN CASES 7 AND 9 WAS RESIDUE WITHIN THE MOTOR GEAR TRAIN. ANALYSES OF CASES 8 AND 11 SHOWED SHAFT BEARING WEAR. ANALYSES FOR CASE 12 REVEALED SHORTING OF THE MOTOR FEEDTHROUGH LIKELY LEADING TO DEVICE FAILURE. THE DEVICE LOG FOR CASE 13 SHOWED RESET CAUSE BY A LOW BATTERY VOLTAGE, BUT DEVICE ANALYSIS WAS UNABLE TO DETERMINE THE CAUSE OF THE FAILURE. THE DEVICE FROM CASE 10 WAS NOT RECEIVED BY THE MANUFACTURER. IT WAS NOTED THAT A SMALL CONTINGENT (N=27) OF PATIENTS RECEIVED THEIR IDDS REFILLS BY A THIRD-PARTY HOME REFILL SERVICE AS OPPOSED TO BEING REFILLED WITH MEDICATION FROM THE DEPARTMENTAL INSTITUTION PHARMACY. AMONG THIS GROUP WHOSE REFILLS WERE PERFORMED BY THE HOME SERVICE, 1 MOTOR STALL WAS NOTED (CASE 5). ANOTHER PATIENT (CASE 8) WAS RECEIVING ROUTINE DEVICE MANAGEMENT AND REFILLS FROM A PROVIDER CLOSER TO HIS HOME WHILE STILL MAINTAINING INTERMITTENT APPOINTMENTS AT THE INSTITUTION AT THE TIME OF DEVICE FAILURE.

    Description of Event or Problem · 1

    ALL INFO PREVIOUSLY REPORTED IN MANUFACTURER REPORT #3007566237-2016-04237 AND #3007566237-2016-04238 PERTAINS TO THIS EVENT (MFR #3007566237-2016-00081).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10469 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention