BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4212205 · Received October 29, 2014

    Report

    Report Number
    3004209178-2014-20643
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    April 26, 2010
    Report Date
    October 2, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. PRODUCT ID: 8575, LOT# J0447118R, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. IT WAS REPORTED THE PATIENT TRANSFERRED CARE TO ANOTHER PHYSICIAN DUE TO THE PREVIOUS HEALTHCARE PROVIDER (HCP) FAILING TO PAY ATTENTION TO THE PATIENT¿S MOTHER¿S PREVIOUS CONCERNS REPORTED UNDER MANUFACTURER REPORT #3007566237-2010-04069 . THE PATIENT¿S MOTHER WAS INFORMED BY THE NEW PHYSICIAN THAT HE HAD ¿NEVER SEEN ANYTHING LIKE THE CONDITION¿ OF THE PATIENT¿S STOMACH.¿ THE PUMP WAS THEN EXPLANTED IN ¿HOPES THAT BY REMOVING IT¿ THE PATIENT¿S MENTAL STATUS AND SWOLLEN STOMACH MIGHT RETURN TO NORMAL AS IT WAS. THE PROCEDURE WAS DONE ON (B)(6) 2012. DURING THE TWO TIMES OF REPLACING THE PREVIOUS PUMPS THE ORIGINAL CATHETER WAS NOT CHANGED IT WAS NOTED. IT WAS ALSO REPORTED THE PATIENT HAD ¿GRADUATED FROM A REGULAR CLASS¿ AND PREVIOUSLY ¿COULD CARRY ON ANY NORMAL CONVERSATION AND VERY SOCIABLE.¿ THAT WAS HOW THE PATIENT WAS ¿UNTIL THAT TIME WHEN HE STARTED TO CHANGE.¿ NOW, THE PATIENT COULD NO LONGER COMMUNICATE NORMAL. THE PATIENT WOULD JUST TALK TO HIMSELF, SCREAMED AND STARED AT WHOEVER WAS TALKING TO HIM. THE PATIENT¿S STOMACH WAS ¿SO HUGE AND SWOLLEN, LIKE A SIZE OF A FOOTBALL ON THE RIGHT SIDE OF HIS STOMACH.¿ THE PATIENT LOOKED ¿SO ABNORMAL MUCH MORE BECAUSE HIS BODY IS SMALL WITH A HUGE STOMACH¿ AND HIS STOMACH WAS NOTED TO BE PROTRUDING. THE PATIENT¿S WAISTLINE WAS (B)(6). IT WAS REPORTED THAT THE PATIENT¿S MOTHER NOW BELIEVED THAT HIS CONDITION WAS RELATED TO THE MALFUNCTION OF THE CATHETER (REFER TO MANUFACTURER REPORT # 3007566237-2010-04069 FOR THE REPORTED CATHETER MALFUNCTION). NO FURTHER INFORMATION WAS REPORTED. IN REGARDS TO MEDICAL HISTORY, THE PATIENT WAS PREVIOUSLY IN THE STUDY PROGRAM OF THE BACLOFEN PUMP. THE PATIENT WAS DISABLED WITH CEREBRAL PALSY, PHYSICALLY DISABLED BUT MENTALLY NORMAL AND COULD TALK AND COMMUNICATE. THE PATIENT WAS CONFINED IN A WHEELCHAIR. THE PATIENT¿S MOTHER TOOK CARE OF HIM ¿24/7.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN SEEN BY MANY PHYSICIAN WHO WERE UNABLE TO DETERMINE THE CAUSE OR ALLEVIATE THE PATIENT¿S BLOATED, SWOLLEN, STOMACH. THE PATIENT¿S STOMACH LOOKED AS IF HE WAS TEN MONTHS PREGNANT AND IT HURT HIM. AN UNDERDOSE WAS ALSO REPORTED AS THE PATIENT HAD AN INCREASE IN BASELINE SPASTICITY. THE DOSE HAD BEEN INCREASED SINCE 2005 BUT THE PATIENT¿S SPASTICITY WAS STILL THE SAME. THE REPORTER WAS CONVINCED IT WAS THE SYNC II BATTERY CAUSING THE PATIENT¿S CONDITION AND WANT IT REMOVED AS SOON AS POSSIBLE TO SEE IF THAT FIXED HER SON¿S PROBLEMS. THE FAMILY HAD THOUGHT THE PUMP WAS IMPACTED BY A PUMP RECALL AND THE HEALTH CARE PROVIDER HAD INFORMED THE FAMILY IT WAS NOT AND THAT A REPLACEMENT WAS NOT WARRANTED. THE PATIENT HAD CHANGED PHYSICIAN¿S AS THE FAMILY HAD ALLEGED THAT THE IMPLANTED DEVICE WAS DEFECTIVE WHEN IN FACT THE HCP STATED IT WAS NOT AND REPORTEDLY THE FAMILY HAD BEEN TOLD BY OTHER HCP¿S IT WAS NOT. THE HCP STATED THE FAMILY COULD NOT BE CONVINCED THAT THE PUMP WAS WORKING CORRECTLY. THE FAMILY HAD THOUGHT NO ONE LISTENED TO THE CONCERNS OF THE PATIENT¿S DECLINING CONDITION. AT ONE POINT, A SEVERE SEROMA FORMED AT THE PUMP SITE OVER THE PUMP LOCATION. INFLAMMATION WAS NOW REPORTED AS WELL IN THE PAST. DUE TO ALL THE MEDICAL PROBLEMS THAT THE PATIENT HAD UNDERGONE, THE PLAN WAS TO TURN THE DEVICE OFF. THE REPORTER WAS TO DISCUSS THIS WITH THE PHYSICIAN ON THE DATE OF THIS CALL. THE PATIENT¿S PUMP WAS TO BE FILLED WITH SALINE RATHER THAN BACLOFEN ON (B)(6) 2011. THE PATIENT WAS TAKING ORAL BACLOFEN. AN HCP FURTHER REPORTED THAT THE PUMP CONTAINED COMPOUNDED BACLOFEN 4000 MCG/ML AND THE CAUSE OF EVENT WAS UNKNOWN. THE PATIENT'S LAST VISIT WAS FOR A PUMP CHECK UNDER FLUOROSCOPY IN WHICH THE CATHETER WAS PATENT AND IN THE INTRATHECAL SPACE AS NOTED ON (B)(6) 2011. THE CATHETER WAS WITHOUT LEAKS AND PATENT AND THE SEROMA POST REPLACEMENT PROCEDURE RESOLVED HOWEVER, THE PATIENT CONTINUED TO REPORT SWELLING AT THE PUMP SITE. NO SURGICAL INTERVENTION OCCURRED AND NO HOSPITALIZATION WAS REQUIRED. THIS PARTICULAR HCP HAD NOT SEEN THE PATIENT SINCE THE PUMP CHECK ON (B)(6) 2011. IT WAS NOW NOTED THAT THE PATIENT¿S STOMACH ISSUES CONTINUED TO THE PRESENT DAY INCLUDING BEING SWOLLEN. THE PATIENT HAD A SIZE 48 WAIST AND THE SWELLING HAD NOT GONE AWAY EVEN THOUGH THE PUMP WAS REPORTEDLY REMOVED IN (B)(6) 2011. REPORTEDLY, NO PHYSICIAN WAS ABLE TO DETERMINE WHAT WAS GOING ON WITH THE PATIENT BUT WAS TOLD THE PATIENT HAD SCAR TISSUE IN HIS STOMACH. SOME IMAGING HAD BEEN PERFORMED BUT NO FLUID HAD BEEN WITHDRAWN FROM THE SITE. AT ONE POINT THE DRUG WAS REPORTED TO HAVE BEEN ¿UP TO 2000 SOMETHING." THE PATIENT WAS CURRENTLY SPASTIC AND ONLY ON ORAL BACLOFEN WHICH WAS NOT HELPING. THE PATIENT¿S MOTHER HAD INQUIRED WHAT TO DO AND SINCE THE PUMP AND CATHETER HAD BEEN EXPLANTED THEY WERE LOOKING FOR A PHYSICIAN TO ADDRESS HER SON¿S MEDICAL NEEDS IN REGARDS TO THE SWELLING OF HIS STOMACH. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692453 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Required Intervention