BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2954845 · Received February 11, 2013

    Report

    Report Number
    3007566237-2013-00440
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 17, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND THE PUMP EXTERIOR CONCAVE SHIELD WHICH AFFECTED IN-VIVO FUNCTION. THERE WAS AN UNDETERMINED ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS SEEN FOR A REFILL AND THEY WERE ABLE TO ASPIRATE THE RESERVOIR, BUT UNABLE TO FILL IT COMPLETELY. THE HCP OBTAINED THE EXPECTED VOLUME BACK AT ASPIRATION. HCP WENT TO FILL THE PUMP AND COULD ONLY PUSH IN 15ML. THE PATIENT DID NOT EXPERIENCE ANY ISSUES WITH THE THERAPY. THE PATIENT CAME BACK FOR THE NEXT REFILL AND THE SAME ISSUE OCCURRED AND THE HCP WAS ONLY ABLE TO FILL 14 ML. IT WAS NOTED THAT IT'S LIKE HE HITS A "WALL" AND WAS NOT ABLE TO FILL FURTHER. THE PUMP WAS DELIVERING DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT A PUMP EXPLANT WAS PLANNED, BUT HAD NOT BEEN SCHEDULED AT THE TIME OF THE REPORT. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THE PATIENT OUTCOME WAS REPORTED AS ¿NO INJURY.¿ IT WAS ALSO NOTED THAT THE PATIENT HAD A DOSE ADJUSTMENT ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PUMP WAS DENTED AND UNABLE TO BE FILLED DUE TO THE INDENTATION. THE PUMP WAS EXPLANTED ON 2014-(B)(6). THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE CAUSE OF THE INDENTATION WAS A FALL. THE PUMP WAS REPLACED ON (B)(6) 2013. A WOUND CHECK WAS DONE ON (B)(6) 2014 AND THE PATIENT WAS DOING FINE.

    Description of Event or Problem · 1

    THIS EVENT WAS ALSO REPORTED UNDER MANUFACTURER REPORT #3007566237-2014-00252 [IT WAS REPORTED THE PUMP WOULD NOT FILL APPROPRIATELY. IT WAS REPORTED THAT ¿UPON REPLACING THE DEVICE THERE WAS A NOTICEABLE INDENTATION ON THE BACKSIDE OF THE PUMP. ADDITIONAL INFORMATION REPORTED THAT THE PUMP WAS DELIVERING DILAUDID. IT WAS REPORTED THE PATIENT DID NOT EXPERIENCE ANY GAP IN THERAPY. THE PHYSICIAN NOTICED THAT HE COULD NOT FILL THE PUMP COMPLETELY WITH 20MLS. IT WAS NOTED THAT IT HAPPENED TWO REFILLS, BACK TO BACK. IT WAS AT THAT TIME THE PHYSICIAN DECIDED TO REPLACE THE PUMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.]. ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED UNDER THIS MANUFACTURER REPORT NUMBER (#3007566237-2013-00440). IT HAD ALSO BEEN REPORTED THE DEVICE MANUFACTURER REPRESENTATIVE DIDN¿T KNOW THE EXACT TIMELINE OF THE EVENT AS HE WAS NOT INVOLVED. IT WAS REPORTED THAT OVER THE COURSE OF SEVERAL REFILLS, THE HEALTH CARE PROVIDER (HCP) WAS ABLE TO FILL THE PUMP LESS AND LESS. THE LAST TIME IT WAS FILLED, ON AN UNKNOWN DATE, THE HCP WASN¿T EVEN ABLE TO FILL IT HALF WAY. WHEN THE PUMP WAS REMOVED, THERE REPORTEDLY WAS A LARGE DENT IN THE PUMP. IT LOOKED LIKE IT WAS COMPRESSION FROM THE INSIDE. THE PATIENT DID NOT TRAVEL TO A HIGH ALTITUDE OR HAVE ANY ACCIDENTS, FALLS OR INJURIES AS FAR AS THE REPORTER KNEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58839 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention