BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1760470 · Received July 15, 2010

    Report

    Report Number
    3007566237-2010-05509
    Event Type
    Injury
    Date Received
    July 15, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 17, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6. CONCLUSION CODE 77 NO LONGER APPLIES TO THIS EVENT. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    IT WAS LATER REPORTED THAT THE PATIENT DID NOT HAVE A PUMP REPLACEMENT ON (B)(6) 2010. SHE HAD HER PUMP EXPLANTED. PER THE REPORTER THE PATIENT RECEIVES ORAL MORPHINE SULFATE AND HYDROCODONE. THE SYMPTOMS THAT THE PATIENT WAS COMPLAINING OF ON JUNE 17 COULD HAVE BEEN RELATED TO WITHDRAWAL SYMPTOMS FROM NOT HAVING HER MORPHINE PUMP IN. THE PATIENT HAS BEEN TO THE OFFICE ON (B)(6), (B)(6), (B)(6), AND (B)(6). SHE HAD NEVER MENTIONED ANY OF THE SYMPTOMS DESCRIBED IN THE PHONE CALL TO THE NURSE. SHE IS DOING FINE.

    Description of Event or Problem · 0

    IT WAS LATER REPORTED THAT THE PATIENT¿S PREVIOUS PUMP ONLY CONTAINED SALINE. THE FINAL PATIENT OUTCOME WAS NOT REPORTED. FURTHER FOLLOW-UP WAS CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    FOLLOWING IMPLANT, THEY DIDN'T HAVE THE MEDICATION, SO THEY FILLED THE PUMP WITH WATER. THEY FILLED THE PUMP WITH MEDICATION THE NEXT DAY; THE PT HAD WITHDRAWAL SYMPTOMS THE FOLLOWING DAY. THEY CALLED THE DOCTOR AND HE SAID THE PUMP WAS UNPRIMED. THE PT EXPERIENCED SWEATING (DIAPHORESIS), MUCUS DIARRHEA, COULDN'T SEE STRAIGHT, LEFT SIDE AFFECTED, FOAMY COUGH, BURNING UP AND FREEZING AT THE SAME TIME AND SHE FEELS LIKE WANTS TO JUMP OFF A BRIDGE. THE PT WAS GIVEN ORAL DILAUDID. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601789 SYNCHROMED Pump, infusion, implanted, programmable LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention CATHETER: MODEL 8731, LOT# N001433234| EXPLANTED:| EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 863740| IMPLANTED:| IMPLANTED:| LOT# NGV004054N| PROGRAMMER: MODEL 8840, SERIAL# UNK| PROGRAMMER: MODEL 8840, SERIAL# UNK| CATHETER: MODEL 8731, LOT# N001433234| EXPLANTED:| IMPLANTED:| LOT# NGV004054N| IMPLANTABLE INFUSION PUMP: MODEL 863740| IMPLANTED:| EXPLANTED: