BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5457309 · Received February 24, 2016

    Report

    Report Number
    3004209178-2016-03388
    Event Type
    Injury
    Date Received
    February 24, 2016
    Date of Event
    January 31, 2016
    Report Date
    February 2, 2018
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-3043-2011, Z-0592-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: CATHETER. PRODUCT ID: 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4). THE PUMP (B)(4) WAS RETURNED FOR ANALYSIS. ANALYSIS OF THE DEVICE FOUND HIGH RESISTANCE ACROSS THE BATTERY.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER AND A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING LIORESAL 2000 MCG/ML; 1869 MCG/DAY VIA AN IMPLANTABLE PUMP. THE DATE OF THE EVENT WAS (B)(6) 2015. IT WAS REPORTED THE PATIENT HAD A SUDDEN LOSS OF THERAPY AND HAD BEEN HAVING SUBCLINICAL SEIZURES SINCE NOVEMBER. THE PATIENT WOULD SLEEP 24-36 HOURS AND WAKE UP INCOHERENT. THE PATIENT FOLLOWED UP WITH A NEUROLOGIST TO RULE OUT "OTHER STUFF." THE PHYSICIAN DID A SPIRAL COMPUTED TOMOGRAPHY DYE STUDY (B)(6) 2016 AND IT "LOOKED GOOD." AN ALARM WAS HEARD AND CONFIRMED BY TELEMETRY. THE LOGS WERE READ AND THE BATTERY WAS DEPLETED. PER THE PUMP LOGS: THE PUMP WAS IN SAFE STATE (B)(6) 2016 18:32, MOTOR STALL RECOVERY OCCURRED (B)(6) 2016 18:32. RESET OCCURRED-LOW BATTERY; PUMP IN SAFE STATE (B)(6) 2016 18:33 PUMP IN SAFE STATE (B)(6) 2016 18:36. MOTOR STALL RECOVERY OCCURRED (B)(6) 2016 18:36. RESET OCCURRED-LOW BATTERY; PUMP IN SAFE STATE (B)(6) 2016 18:37. THE CAUSE OF THE LOW BATTERY RESET; SAFE STATE WAS NOT DETERMINED. THE PUMP AND CATHETER WERE REPLACED (B)(6) 2016. THE CATHETER WAS FOUND ON TOP OF THE PUMP IN SURGERY AND LEAKED CEREBROSPINAL FLUID. THERE WAS NO PATIENT INJURY. INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO RECEIVED LIORESAL BACLOFEN (2000MCG/ML, 1900MCG/DAY, LOT# DS0078N05) IN AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY AND OTHER SPASTICITY. FOLLOWING AN MRI AND CT, THE PUMP LOGS SHOWED "RESET OCCURRED-LOW BATTERY" AND "PUMP IN SAFE STATE" AT 12:02 HOURS. THE MRI OCCURRED AT 10:40 HOURS AND CORRESPONDS WITH THE MOTOR STALL. NO MOTOR STALL RECOVERY WAS NOTED. FOLLOWING THE MRI, THE PATIENT HAD A DYE STUDY/SPIRAL CT. THE PHYSICIAN NOTED THE PUMP REVERTED TO MINIMUM RATE MODE UPON INTERROGATION TO PROGRAM A CATHETER PRIME FOLLOWING SUCCESSFUL CATHETER ACCESS PORT (CAP) ACCESS. THE PUMP WAS REPROGRAMMED TO THE DESIRED DOSE. A DIFFERENT PHYSICIAN READ THE PUMP LOGS FOLLOWING THE MRI AND SPIRAL CT AND DISCOVERED THE LOW BATTERY RESET, SAFE STATE MESSAGES. ADDITIONAL INFORMATION WAS REQUESTED FROM THE HEALTHCARE PROVIDER (HCP) REGARDING CONCOMITANT MEDICATIONS, PERTINENT MEDICAL HISTORY, RESULTS AND REASON FOR MRI/SPIRAL CT, TROUBLESHOOTING PERFORMED, IF THE CAUSE OF THE ISSUE WAS DETERMINED, IF THE PATIENT EXPERIENCED SYMPTOMS, AND ACTIONS/INTERVENTIONS REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A CONSUMER INDICATED THERE WAS A PUMP FAILURE AND THE PATIENT EXPERIENCED SPASTICITY. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112931 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00020 YR Required Intervention