BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3132991 · Received May 29, 2013

    Report

    Report Number
    3007566237-2013-01764
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8703, LOT# J90070744, IMPLANTED: (B)(6) 1990. PRODUCT TYPE: CATHETER: PRODUCT ID 8840, SERIAL# UNKNOWN. PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DRUG IN THE PUMP WAS LIORESAL. THE CAUSE OF THE EVENT WAS REPORTED AS ¿THE PUMP BATTERY DIED¿ (AS PREVIOUSLY REPORTED). A MOTOR STALL WAS NOTED FOR ONE DAY, WITH NO RECOVERY NOTED. IT WAS ALSO NOTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013 WITH SEPSIS AND OSTEOMYELITIS. THE HCP PLANNED PROPHYLACTIC REPLACEMENT OF THE PUMP ONCE THE PATIENT WAS STABLE; HOWEVER, THE ¿BATTERY DIED¿ BEFORE THE PATIENT WAS STABILIZED. A PUMP REPLACEMENT OCCURRED ON (B)(6) 2013. THE PATIENT SYMPTOMS INCLUDED DIAPHORESIS, SUDDEN INCREASE IN SPASMS AND HYPOTENSION. THE PATIENT OUTCOME WAS REPORTED AS SERIOUS LIFE THREATENING INJURY/ILLNESS-RECOVERED WITH SEQUELAE. IT WAS NOTED THE PATIENT¿S SPASMS WERE ¿BACK TO NORMAL¿ AND THE PATIENT WAS BACK ON THEIR ¿PRE-EVENT¿ DOSE OF 500 MCG/DAY AND THE PATIENT CONTINUED TO RECOVER FROM OSTEOMYELITIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS CURRENTLY IN THE HOSPITAL WITH A ¿RAGING INFECTION¿. THE CALLER STATED THAT THE PATIENT HAD A BONE INFECTION IN HIS KNEE AND HE MAY END UP WITH AN AMPUTATION. THE CALLER STATED THAT THEY HAD BEEN TRYING TO REPLACE THE PATIENT¿S PUMP FOR THE PAST TWO MONTHS; HOWEVER, EVERY TIME THEY HAVE THE PATIENT ON THE SCHEDULE HE ¿GETS SICK¿. THE CALLER ATTEMPTED TO REFILL THE PATIENT¿S PUMP BUT THE PUMP PRESENTED A TERMINAL ERROR INDICATING THAT THE PUMP BATTERY EXPIRED. THE CALLER STATED THE PUMP DIED THE DAY PRIOR TO THE REPORT, (B)(6) 2013. THE PATIENT HAD BEEN HAVING SPASMS AND TOLD THE CALLER THAT HE HAD BEEN HAVING THEM FOR WEEKS. THE CALLER ALSO STATED THAT THEY THOUGHT THE PATIENT HAD E. COLI AS THE PATIENT HAD AN ULCER, HAD BEEN CONSTIPATED AND ¿THERE¿S SO MUCH GOING ON WITH HIM¿. THE CALLER STATED THAT THEY WERE GOING TO GIVE THE PATIENT ORAL BACLOFEN. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236939 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention