BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5099494 · Received September 24, 2015

    Report

    Report Number
    3007566237-2015-02715
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    August 7, 2015
    Report Date
    August 30, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED: ANALYSIS OF THE PUMP FOUND A GEAR TRAIN ANOMALY DUE TO CORROSION AND/OR WEAR AND/OR LUBRICATION AS WELL AS STALL DUE TO SHAFT-BEARING.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP), COMPANY REPRESENTATIVE AND A CONSUMER REGARDING A PATIENT RECEIVING INTRATHECAL COMPOUNDED BACLOFEN 2000 MCG/ML; 1480.1 MCG/DAY VIA AN IMPLANTED PUMP. THE INDICATION FOR USE WAS INTRACTABLE SPASTICITY AND CEREBRAL PALSY. THE PATIENT EXPERIENCED A SUDDEN CHANGE IN THERAPY/ SYMPTOMS NOTED AS AN INCREASE IN SPASTICITY ON (B)(6) 2015. THE PATIENT'S MOTHER HEARD AN ALARM AND REPORTED THE PATIENT WAS "TIGHT". THE HCP COULD NOT HEAR THE PUMP ALARMING WHEN SHE STOOD NEXT TO THE PATIENT BUT THE PARENTS REPORT HEARING THE CRITICAL ALARM; TELEMETRY DID NOT CONFIRM THE ALARM. THE PUMP WAS INTERROGATED BY ANOTHER HCP AND THERE WAS NO INDICATION THAT THE PUMP WAS ALARMING. THE EVENT DATE WAS (B)(6) 2015. THE PUMP AND THE LOGS WERE READ. MULTIPLE MOTOR STALLS OCCURRED FOR NO EXPLAINED REASON. (B)(6) 2015 18:21 MOTOR STALL; (B)(6) 2015 06:56 MOTOR STALL RECOVERY OCCURRED, (B)(6) 2015 10:06 MOTOR STALL OCCURRED; (B)(6) 2015 18:31 MOTOR STALL RECOVERY OCCURRED, (B)(6) 2015 22:01 MOTOR STALL OCCURRED; (B)(6) 2015 23:04 MOTOR STALL RECOVERY OCCURRED, (B)(6) 2015 00:56 MOTOR STALL OCCURRED. (B)(6) 2015 18:47 MOTOR STALL RECOVERY OCCURRED; (B)(6) 2015 20:07 MOTOR STALL OCCURRED. THE LAST MOTOR STALL HAD NOT RECOVERED WHEN PUMP WAS READ ON (B)(6) 2015 AT 1145AM. PATIENT STATUS WAS ALIVE; NO INJURY. THE LAST MOTOR STALL OCCURRED AT (B)(6) 2015 AT 20:07. IT HAD NOT RECOVERED WHEN THE PUMP WAS CHECKED ON (B)(6) 2015 AT 1145AM. THE PUMP WAS SET TO MINIMUM RATE PER THE PHYSICIAN UNTIL REPLACEMENT. THE PLAN WAS TO REPLACE THE PUMP ON (B)(6) 2015. IT WAS ALSO REPORTED THE PLAN WAS TO REPLACE THE PUMP ON (B)(6). IT WAS UNCLEAR WHEN THE REPLACEMENT WOULD OCCUR. THE ISSUE HAD NOT BEEN RESOLVED. THE CAUSE OF THE EVENT, THERAPY DATES AS WELL AS CONCOMITANT DRUGS AND PATIENT OUTCOME WERE NOT REPORTED; ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633446 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Required Intervention