BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2883399 · Received December 21, 2012

    Report

    Report Number
    3004209178-2012-12158
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    November 15, 2012
    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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE CATHETER. FOR USE BY USER FACILITY/IMPORTER(DEVICES ONLY). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE ADVERSE EVENTS WHILE ON PRIALT. IN (B)(6) 2012 THE PATIENT GOT WEAKER EACH WEEK AND EVENTUALLY COULD NOT TAKE WALKS WITH HIS DOG; HE COULD NOT REMEMBER AND COULD NOT CONCENTRATE, ESPECIALLY WHEN DRIVING. THE PATIENT ALSO EXPERIENCED "MEMORY ISSUES". AT THE TIME OF THIS REPORT, THE PATIENT STILL HAD SOME WEAKNESS; HIS CONCENTRATION WAS 'BETTER NOW BUT NOT 100 PERCENT". THIS ADVERSE EVENT HAD IMPROVED BUT WAS STILL PRESENT. IN (B)(6) 2012 THE PATIENT BEGAN TO HEAR "MUSIC" THROUGH AIR CONDITIONING VENTS, WASHING MACHINES, AND PUMPS. AT THE TIME OF THIS RE PORT, THE ADVERSE EVENT HAD BEEN RESOLVED. IN (B)(6) 2012 THE PATIENT EXPERIENCED "BROWN MOUTH," A "COATING ON HIS TEETH" THAT HE COULD REMOVE WITH A "WATER PICK"; BUT THE COATING RETURNED IN SECONDS. THE PATIENT COULD STILL EAT AND THE COATING WAS SOFTER THAN HIS TEETH. TWO DAYS LATER, THE PATIENT DEVELOPED WHAT WAS DESCRIBED AS "GRASS CELERY STICKING OUT OF HIS MOUTH," AND "SOMETHING WAS STUCK TO THE BACK OF THE TEETH". THE PATIENT STATED THAT TWO DOCTORS AND TWO DENTISTS COULD NOT DIAGNOSE THIS PHENOMENON OF "GRASS AND CELERY STICKING OUT OF HIS MOUTH AND SOMETHING STUCK TO THE BACK OF THE TEETH." THE PATIENT VISITED A DOCTOR AT WHO WAS FAMILIAR WITH PRIALT ADVERSE EVENTS AND DESCRIBED THE PHENOMENON AS A "TOTAL ILLUSION." THE PATIENT REQUESTED A DOSE INCREASE OF PRIALT AND COMPLAINED THAT THE MEDICATION WAS "TOO LOW AND DID NOT HIT THE BELL". THE PATIENT REQUESTED THAT THE LEADS FROM THE PUMP BE EXAMINED. IN (B)(6) 2012, AN X-RAY DETERMINED THAT SURGERY WAS REQUIRED TO RECONNECT AND REPOSITION THE "LINES" FROM THE PUMP. DURING THE SURGERY, THE DOCTOR WAS "SHOCKED AT WHAT HE SAW". THE PATIENT WAS NOT GIVEN AN EXPLANATION OF WHAT THE DOCTOR WITNESSED DURING THE SURGERY, BUT THE PATIENT THEORIZED THAT "THE PRIALT MAY HAVE LEAKED AND AFFECTED HIS BRAIN". THE PATIENT WAS HOSPITALIZED FOR ONE DAY FOLLOWING THE SURGERY. IN (B)(6) 2012, THE PATIENT'S SIDE EFFECTS WERE DESCRIBED AS "AUDITORY HALLUCINATIONS" AND THE PATIENT COMPLAINED OF "TOOTH SMOKE". IT WAS UNCLEAR WHAT WAS MEANT BY "TOOTH SMOKE". THE DRUG USED WITHIN THE PUMP WAS PRIALT. THE PATIENT OUTCOME WAS NOTED TO BE "NON-SERIOUS INJURY/ILLNESS". NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R