BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 6724675 · Received July 19, 2017

    Report

    Report Number
    3004209178-2017-15113
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Date of Event
    March 28, 2017
    Report Date
    August 1, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0592-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(6). MRI MOTOR STALL DATE (B)(6) 2008 INCLUSION/EXCLUSION CRITERIA OR COMMONLY USED WORDS FOR REPORTING SCENARIOS TELEMETRY STATE/ FALSE MOTOR STALL/ GEAR BINDING/ UNRECOVERED STALL FOLLOWING MRI - GEAR BINDING IS ASSOCIATED WITH AN MRI AND IS REPORTED AS AN EXPLANATION OF WHY THE PUMP STALLED. THIS CAN'T BE CONFIRMED BY ANALYSIS INCLUSION CRITERIA: -AT LEAST ONE OF THE FOLLOWING RFR¿S IS APPLIED AND DOES NOT HAVE CON CODE (B)(4) TIED TO IT: (B)(4) EXCLUSION CRITERIA: -THE STALL IN QUESTION IS A NORMAL MOTOR STALL DUE TO MRI (I.E. RECOVERY WITHIN 2 HOURS) AND (B)(4) IS APPLICABLE REASON FOR RECALL MEDTRONIC ISSUED A LETTER TO HEALTHCARE PROFESSIONALS PROVIDING IMPORTANT SAFETY INFORMATION REGARDING MRI (MAGNETIC RESONANCE IMAGING) EFFECTS ON SYNCHROMED EL AND SYNCHROMED II IMPLANTABLE INFUSION PUMPS. AS STATED IN PRODUCT LABELING, THE MAGNETIC FIELD OF AN MRI WILL TEMPORARILY STOP THE ROTOR OF THE PUMP MOTOR AND SUSPEND DRUG INFUSION FOR THE DURATION OF MRI EXPOSURE FOR ALL SYNCHROMED PUMP DEVICE MODEL AND Z #/NOTIFICATION MODELS AFFECTED: MODEL 8627-10, (B)(4); MODELS AFFECTED: MODEL 8626L-18, ALL SERIAL NUMBERS (B)(4); MODELS AFFECTED: MODEL 8626-18, ALL SERIAL NUMBERS (B)(4); MODELS AFFECTED: MODEL 8626-10 ALL SERIAL NUMBERS. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ON 2017-JULY-20, ADDITIONAL INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROFESSIONAL (HCP) VIA A PRODUCT SURVEILLANCE REGISTRY (PSR) UPDATE. IT WAS REPORTED THE PATIENT WAS RECEIVING BACLOFEN (500 MCG/ML AT A DOSE OF 160 MCG/DAY AT AN INFUSION RATE OF 0.32). ON 2017-JULY-26, ADDITIONAL INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROFESSIONAL (HCP) VIA A PRODUCT SURVEILLANCE REGISTRY (PSR) UPDATE. ADDITIONAL INFORMATION CONFIRMED THERE WAS NO VOLUME DISCREPANCY OF THE EXPECTED RESERVOIR VOLUME (ERV) AND THERE WERE NO SYMPTOMS. THERE WERE NO INTERROGATIONS AFTER (B)(4) 2017 AND LOGS WERE NOT AVAILABLE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROVIDER (HCP) VIA A PRODUCT SURVEILLANCE REGISTRY (PSR) REGARDING A PATIENT WHO RECEIVED AN UNKNOWN DRUG IN AN IMPLANTABLE PUMP AN UNKNOWN INDICATION FOR USE. DURING INTERROGATION OF A PUMP ON (B)(6) 2017 A MOTOR STALL WAS OBSERVED TO HAVE OCCURRED ON (B)(6) 2017. PER THE PATIENT, AN MRI OCCURRED THAT DAY. THE LOGS INDICATED A MOTOR STALL (ALSO REPORTED AS PUMP STOP) OCCURRED, BUT CLINICALLY THE PATIENT DID NOT EXPERIENCE SYMPTOMS ASSOCIATED WITH A MOTOR STALL (SPASTICITY OR ITCHING). THE RESIDUAL VOLUME WAS REPORTEDLY 9 ML AND THE RESIDUAL VOLUME WOULD HAVE BEEN GREATER IS THE MOTOR STALL OCCURRED WITHOUT RECOVERY ("SHOULD BE +- 40ML LEFT IN PUMP"). THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELA AS OF (B)(6) 2017. NO FURTHER ACTIONS WERE REQUIRED. THERE WERE NO REPORTED PATIENT SYMPTOMS. NO COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506948 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1