BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 979872 · Received January 15, 2008

    Report

    Report Number
    2182207-2008-00250
    Event Type
    Injury
    Date Received
    January 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 30, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF FINAL DEVICE ANALYSIS SHOWS A MOTOR WIRE FEED-THRU ANOMALY WAS DETECTED. MICROSCOPIC INSPECTION OF THE CIRCUIT BOARD, MOTOR WIRES, AND BATTERY WIRES REVEALED NO ANOMALY FOUND. EVALUATION OF ALL GEARS SHOWS NO SHAFT WEAR WAS DETECTED. ANALYSIS RESULTS CONFIRMED THE REASON FOR DEVICE RETURN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AS SHE HEARD AN ALARM. THE PATIENT'S MOTHER FELT THE PATIENT WAS GETTING TOO MUCH MEDICATION AS THE PATIENT EXPERIENCED RETURN OF SYMPTOMS (UNSPECIFIED), AS WELL AS OVERDOSE SYMPTOMS INCLUDING SEDATION AND FLACCIDITY INTERMITTENTLY. THE PATIENT WAS BRIEFLY HOSPITALIZED FOR OBSERVATION AND EVALUATION DUE TO FEVER OF 100.3F, DEHYDRATION AND A URINARY TRACT INFECTION. SHE WAS DISCHARGED TO THE CARE OF HER MOTHER UNTIL THE PUMP WAS REPLACED. THE PATIENT WAS STARTED ON LEVOFLOXACIN DUE TO GRAM POSITIVE AND NEGATIVE FLORA FROM TRACHEAL ASPIRATE. XRAYS REVEALED ASPIRATION PNEUMONIA AND A URINE CULTURE WAS POSITIVE FOR STREPTOCOCCUS. OXYGEN SATURATIONS WERE RECORDED AS >90%. SHE WAS ALSO PRESCRIBED ORAL BACLOFEN 20 MG EVERY SIX HOURS AS NEEDED FOR SPASTICITY. UPON INTERROGATION, THE PUMP WAS FOUND TO BE IN SAFE STATE WITH MULTIPLE STALLS AND RESETS SINCE 2007 AND HAS BEEN INFUSING AT MINIMUM RATE FOR APPROXIMATELY A DAY AND A HALF. THE PUMP IS ALSO SHOWING A LOW BATTERY ALARM AND CRITICAL ALARM DUE TO THE MOTOR STALL. THE PUMP WAS ORIGINALLY PROGRAMMED TO DELIVER LIORESAL 2000 MCG/ML 551.4 MCG/DAY IN A FLEX PROGRAM, BUT WAS ONLY DELIVERY 12.9 MCG/DAY. A PUMP REPLACEMENT WAS PLANNED FOR 2008.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE PATIENT'S MOTHER HAD TAKEN THE PATIENT TO THE EMERGENCY ROOM ON (B)(6) 2008 AND IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE WAS 143/100 AND THE PATIENT WAS SLEEPY AND LISTLESS WHICH WAS UNUSUAL FOR HER. THE PATIENT WAS PLACED ON AN OXIMETER AND IT WAS NOTED THAT HER O2 SATURATION WAS 84. THE HCP INDICATED TO HER THAT IT WAS UNLIKELY THAT THE PATIENT WAS HAVING AN OVERDOSE, BUT IT WAS MORE LIKELY THAT IT WAS UNDERDOSE SYMPTOMS SHE EXPERIENCED. THE PATIENT WAS PRESCRIBED ORAL BACLOFEN AND DISCHARGED TO HOME IN THE CARE OF HER MOTHER. AFTER CONSULTATION WITH THE MANUFACTURER WHILE AT HOME, THE PATIENT'S MOTHER RETURNED TO THE HOSPITAL AND THE PATIENT WAS ADMITTED AND THE PUMP WAS FOUND TO BE MALFUNCTIONING. DURING THE HOSPITALIZATION, THE PATIENT'S HEART RATE WAS 150 AND O2 SATURATIONS WERE 82. THE PATIENT EXPERIENCED EXTENSOR TONE, TWITCHING, PAIN AND LACK OF RESPONSIVENESS. THE PUMP WAS REPLACED ON (B)(6) 2008.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE ADMISSION DIAGNOSES INCLUDED: RECENT INFLUENZA REQUIRING ISOLATION; SMALL SACRAL DECUBITUS ULCER AND EPILEPSY. THE RECORD ALSO NOTED THAT THE PATIENT HAD A PERMANENT TRACHEOSTOMY; PERMANENT G-TUBE AND A FOLEY CATHETER. THE PATIENT WAS DESCRIBED AS NON-VERBAL. THE PATIENT REQUIRED THREE DOSES OF NARCAN BY THE ANESTHESIOLOGIST AT IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| R "SEE H10...."| CATHETER MODEL 8709 LOT# J10840R26| EXPLANTED| EXPLANTED| IMPLANTED| IMPLANTED| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED| IMPLANTED| EXPLANTED| IMPLANTED| CATHETER MODEL 8709 LOT# J10840R26| PROGRAMMER MODEL 8840 LOT# UNK