BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2100645 · Received May 12, 2011

    Report

    Report Number
    3007566237-2011-03478
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Report Date
    April 27, 2011
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL RESULTS OF THE PUMP (MODEL 863720, SN# (B)(4)) REVEALED NO ANOMALY, AS THE DEVICE WAS FOUND TO FUNCTION NORMALLY. NO PUMP TUBE LEAKS WERE SEEN. THE BATTERY VOLTAGE WAS 3.04V. THE PUMP RAN FOR 2 MINUTES AT 24,000 UL/DAY; AND THE BATTERY LOGS OF THE BCT FILE SHOWED .19 VOLT DROP. NO ANOMALIES WERE FOUND IN REGARDS TO THE FOLLOWING: BOTTOM BRIDGE ASSEMBLY, GEAR NUMBERS 1 THROUGH 3, MAGNET GEAR, AND THE PUMP HEAD. THERE WAS RESIDUE AND A LACK OF LUBRICATION ON THE UPPER JEWEL OF GEAR #2, BUT ALL OTHER JEWEL LUBRICATION WAS ACCEPTABLE. UNDER A MICROSCOPE, NO ANOMALIES WERE FOUND REGARDING THE CIRCUIT BOARD, BATTERY, POSTS, AND MOTOR WIRES. IN REGARDS TO M1 AND M2 MOTOR RESISTANCE TO CASE, THE FOLLOWING WAS NOTED: PASS, AND RESISTANCE GREATER THAN 10 MEG. NO MOISTURE WAS SEEN ON THE BOTTOM OF THE INNER COVER, PUMP HEAD, OR MOTOR COMPARTMENT. MOTOR COIL RESISTANCE WAS 488 OHMS. NO MOTOR STALLS WERE SEEN DURING TESTING. THE PUMP PASSED PATENCY TESTING. ALL LOGS AND TELEMETRY STIRPS WERE REVIEWED AND NO LOW BATTERY RESET, ERI, OR SAFE STATE EVENTS WERE INDICATED. THE RESERVOIR WAS FOUND TO BE EMPTY. ANALYSIS OF THE CATHETER (MODEL 8703W, LOT/SN# (B)(4)) REVEALED A HOLE WHICH WAS DETERMINED TO BE USER RELATED. THE DIMENSIONS OF THE RETURNED CATHETER INCLUDED THE FOLLOWING: PUMP CONNECTOR AND 23.2 CM PROXIMAL SEGMENT, 17.4 CM PROXIMAL SEGMENT WITH PIN CONNECTOR WHICH INCLUDED THE STRAIN RELIEF SHROUD. AN AREA OF ABRASION WAS SEEN 5.3 TO 6.7 CM FROM THE PROXIMAL END OF THE 23.3 CM PROXIMAL SEGMENT. IT WAS IN THE AREA OF ABRASION THAT THE HOLES WERE FOUND. THE ABRASION WENT DEEP ENOUGH TO REACH THE INNER LUMEN, WHICH CAUSED LEAKING TO OCCUR. SEVERAL AREAS OF DEPOSITS ON THE SURFACE OF THE CATHETER WERE SEEN. THE 23.3 CM PROXIMAL SEGMENT FAILED A 30 PSI PRESSURE TEST, WHILE THE OTHER SEGMENT PASSED. THE CATHETER PASSED PATENCY TESTING. ANALYSIS OF THE CATHETER (MODEL UNK/DAS, SN# UNK) REVEALED A CATHETER ANCHOR ANOMALY. EXPLANT DAMAGE WAS SUSPECTED IN REGARDS TO THE FOLLOWING: THE V-WING ANCHOR HAD A BREACH IN THE SUTURE HOLE ON ONE OF THE WINGS, AND THE BODY OF THE ANCHOR HAD 3 SLICE CUTS. A SLICE CUT WAS FOUND IN THE 4.5 CM DISTAL SEGMENT; .3 CM FROM ONE OF ITS ENDS. THE 4.5 CM DISTAL SEGMENT FAILED A 30 PSI PRESSURE TEST DUE TO THE SLICE CUT, WHILE THE OTHER SEGMENTS PASSED. THE CATHETER PASSED PATENCY TESTING. IT WAS NOTED THAT ANALYSIS REFERS ONLY TO THE DISTAL PORTIONS OF THE RETURNED CATHETER SEGMENTS. IT CANNOT BE DETERMINED WITH CERTAINTY WHAT THE MODEL NUMBER WAS OF THESE RETURNED DISTAL SEGMENTS, BUT THE TYPE OF DISTAL DISPENSING HOLES SHOW THE DISTAL SEGMENTS ARE NOT PART OF A MODEL 8703W CATHETER.

    Description of Event or Problem · 1

    ON (B)(6) 2010, IT WAS INITIALLY REPORTED THAT THE PT EXPERIENCED WITHDRAWAL SYMPTOMS YESTERDAY, AND WAS NEVER HAVING THERAPEUTIC EFFECT. NO VOLUME DISCREPANCIES WERE NOTED. ON (B)(6) 2010, IT WAS FURTHER REPORTED THAT THE PT'S DOSE WAS CURRENTLY BEING LOWERED AS THE PT WANTED THE PUMP EXPLANTED. A ROTOR AND DYE STUDY WERE PERFORMED, AND THE RESULT OF EACH TEST WAS NOTED AS BEING "FINE." THE PT'S CURRENT MEDICATION INCLUDED THE FOLLOWING: COMPOUNDED BACLOFEN, FENTANYL, CLONIDINE, AND BUPIVACAINE. THE PT DID NOT HAVE WITHDRAWAL SYMPTOMS, AND WAS REPORTED AS "DOING FINE." ON (B)(6) 2010, THE DOSES WERE STILL BEING TAPERED, AND THE PT WAS STILL DOING FINE. ADD'L INFO RECEIVED ON 03/29/2011 INDICATED THAT THE PUMP AND CATHETER WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1