BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4011422 · Received August 14, 2014

    Report

    Report Number
    3004209178-2014-15361
    Event Type
    Injury
    Date Received
    August 14, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# L56458, IMPLANTED: (B)(6) 1998, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDERDOSE SYMPTOMS WHICH WERE SPECIFIED AS WITHDRAWAL, TREMOR, CONFUSION, SKIN TONE CHANGES IN THE LEGS, IRRITABILITY, AND LESS THAN 50% THERAPY RELIEF. ADDITIONALLY, THE PATIENT HAD FEELINGS OF BUGS CRAWLING ALL OVER HER. THE PATIENT WAS HOSPITALIZED AND A ROTOR/ROLLER STUDY WAS PERFORMED. THE ROTOR STUDY WAS NORMAL, BUT THE DECISION WAS MADE TO REPLACE THE PUMP TO ALLOW THEM TO SWITCH THE MEDICATION IN THE FUTURE TO A LOWER CONCENTRATION WITH A REASONABLE REFILL INTERVAL. IT WAS REPORTED THAT THERE WAS NO ALLEGED PRODUCT ISSUE WITH REGARD TO THE PUMP. ADDITIONALLY, IT WAS ALSO REPORTED THAT THERE WAS OCCLUSION AT THE CATHETER TIP WHICH REQUIRED REPLACEMENT. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING, WITH REGARD TO THE CATHETER, WAS PERFORMED; IT WAS REPORTED THAT IT WAS NOT REQUIRED. IT WAS SPECIFIED THAT THE CAUSE OF THE PRODUCT ISSUE WAS THAT THE DISTAL PORTION OF THE CATHETER HAD DARK RESIDUE RESEMBLING DRUG PRECIPITATE BUILD UP. THERE WERE NO VOLUME DISCREPANCIES AND THE CATHETER WAS NOT ASPIRATED, DUE TO THE PHYSICIAN PLANNING FROM THE BEGINNING TO REPLACE THE CATHETER. AS OF (B)(6) 2014, THE PATIENT¿S STATUS WAS REPORTED AS ALIVE WITH INJURY. THE PUMP WAS BEING USED TO DELIVER MORPHINE 50 MG/ML AT 11.9 MG/DAY AND CLONIDINE 500 MCG/ML AT 119 MCG/DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ON 10/8/2014 INFORMATION WAS RECEIVED INDICATING THAT THE CAUSE OF THE ISSUE WAS BLACK PRECIPITATE IN THE CATHETER. NOTHING ADDITIONAL WAS EVER DONE AS THE PHYSICIAN WAS PLANNING TO REPLACE THE CATHETER ALL ALONG. THEY HAD NOT HEARD FROM THE PATIENT OR DOCTOR SINCE THE SURGERY. IT WAS THOUGHT THAT EVERYTHING WAS GOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486348 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Hospitalization| R