BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3122800 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-04433
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    August 22, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NOT SEEN THEIR PHYSICIAN FOR A YEAR AND THE PUMP WAS DRY. THE ALARM HAS BEEN GOING OFF EVERY HOUR SINCE (B)(6) 2012. THE PATIENT HAD BEEN TRYING SINCE (B)(6) TO OBTAIN THEIR MEDICAL RECORDS FROM THE PHYSICIAN BUT THE RECORDS WERE NOT RELEASED TO HER. THE PATIENT CONTINUED TO EXPERIENCE DIFFICULTY FINDING A PHYSICIAN TO MANAGE HER CARE. THE PATIENT DID NOT CURRENTLY HAVE A PHYSICIAN TO MANAGE HER CARE. THE LAST REFILL WAS (B)(6) 2012 AND AT THAT POINT THEY NEEDED A REVISION SURGERY. THE SURGERY WAS SCHEDULED BUT DUE TO INSURANCE AND MOVING OUT OF THE COUNTY THEY WERE NOT BE ABLE TO DO SURGERY. THE PATIENT WAS HAVING CATHETER ISSUES AND NEEDS TO HAVE BLOOD PATCH DONE AS IT WOULD SWELL UP. THEY FELT PRESSURE, ¿LIKE SOMEONE¿S KIND OF STEPPING ON YOU.¿ THE CATHETER ISSUES HAVE BEEN GOING ON SINCE (B)(6). THE PATIENT WAS ¿AT THE END OF MY ROPE¿ AND CURRENTLY HAVING TO LAY ON HEATING PAD DAY AFTER DAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP FELL FROM PATIENT¿S ABDOMEN DOWN TO HER HIP BONE ABOUT 4 MONTHS PRIOR TO THE DATE OF THIS REPORT. THE PATIENT COULD FELT THE PUMP RUBBING AS SHE WALKS. IT WAS ALSO NOTED THAT THE CATHETER ¿CROSSED OVER¿ HER SPINE AND WAS PUTTING PRESSURE ON THE SPINE. THE PATIENT WAS EXPERIENCING NUMBNESS AND TINGLING IN HER RIGHT HAND. HER LEFT PINKY WAS SPASTIC AND HER RIGHT FOOT WAS COMPLETELY NUMB. THE PATIENT WAS SCHEDULED TO HAVE THE PUMP AND CATHETER REVISED ON (B)(6) 2012, BUT THE PATIENT HAD BEEN INFORMED THAT SHE WILL NEED TO FIND A NEW DOCTOR SINCE SHE MOVED TO THE WEST COAST OF (B)(6). THE PATIENT WAS HAVING DIFFICULTY FINDING A DOCTOR TO SEE HER FOR 2 MONTHS FROM THE DATE OF THIS REPORT. THE PUMP WAS USED TO DELIVER DILAUDID AND AN UNKNOWN DRUG. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL DID NOT HAVE A MANAGING PHYSICIAN. IT WAS ALSO STATED THAT THE PATIENT HAD DIFFICULTY RECEIVING HER MEDICAL RECORDS FROM HER CLINIC, BUT WAS ABLE TO GET THEM THROUGH HER HOSPITAL. THE PATIENT ALSO RESTATED ISSUES WITH PUMP AND CATHETER MIGRATION. IT WAS MENTIONED THAT THE PATIENT NOTICED THE PUMP MOVED A COUPLE MONTHS BEFORE THE REVISION AND THE HCP AT THE TIME THOUGHT IT WAS DUE TO THE PATIENT'S MUSCLES. IT WAS NOTED THAT THE PATIENT'S PRIMARY HCP WAS WORRIED ABOUT THE POTENTIAL FOR INFECTION WITH THE PUMP STILL IN THE PATIENT'S BODY. THERE WERE NO SIGNS, SYMPTOMS, OR DIAGNOSIS FOR INFECTION AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223792 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention