BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 5457438 · Received February 24, 2016

    Report

    Report Number
    3007566237-2016-00991
    Event Type
    Injury
    Date Received
    February 24, 2016
    Report Date
    March 29, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THIS MDR AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT THIS DEVICE MALFUNCTIONED. THIS DEVICE DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8637-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: PUMP. PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: CATHETER. (B)(4). THE CATHETER ((B)(4)) WAS RETURNED FOR ANALYSIS. ANALYSIS OF THE DEVICE FOUND NO SIGNIFICANT ANOMALY, THE DEVICE WAS RETURNED IN SEGMENTS.

    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 (B)(6). 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. IT WAS UNKNOWN WHY THE PUMP WENT TO SAFE STATE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115084 INDURA PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8711

    Patients

    Seq Age Sex Outcome Treatment
    1 00020 YR Required Intervention