BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VECTRIS LEAD

    MDR report key: 3181532 · Received June 21, 2013

    Report

    Report Number
    3007566237-2013-02044
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37081-40, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE TRIAL EXTENSION AND LEAD WERE ¿PULLED AND EXTERNALIZED THROUGH THE PATIENT¿S SKIN.¿ THIS WAS NOT NOTICED UNTIL THE PATIENT WAS HAVING THEIR ¿STAGE 2¿ COMPLETION PHASE. IT WAS NOTED AS THE LEAD HAD BEEN EXTERNALIZED IN A NON-CLEAN AREA, THE SURGEON HAD NO OPTION BUT TO ABANDON THE PLANNED COMPLETION AND EXPLANT THE TRIAL LEAD AND EXTENSION FULLY. IT WAS NOTED THE PATIENT HAD FELT A SHARP ¿STABBING¿ SENSATION APPROXIMATELY 6 DAYS PRIOR. THE PATIENT HAD THEIR WIFE CHECK THE WOUND SITE AND TESTED THE TRIAL SYSTEM WITH AN EXTERNAL STIMULATOR AND EVERYTHING WAS WORKING EFFECTIVELY. THE PATIENT DID NOT REPORT THE INCIDENT TO THEIR PHYSICIAN. THE EXTERNALIZED LEAD WAS NOT NOTICED DURING ROUTINE FOLLOW UP AND WAS ALSO NOT NOTICED BY MEDICAL STAFF WHEN THE DRESSING WAS REMOVED PRIOR TO SURGERY. IT WAS NOTED THE ¿POCKET¿ FOR THE STIMULATOR HAD BEEN CREATED PRIOR TO NOTING THE ISSUED WITH THE LEAD AND EXTENSION. IT WAS PLANNED FOR THE PATIENT TO HAVE ANOTHER LEAD IMPLANT AND TO CONNECT THE STIMULATOR. PATIENT STATUS WAS NOTED AS ALIVE WITH INJURY. PATIENT SYMPTOMS INCLUDED PAIN AT THE POCKET SITE. FOLLOW UP REPORTED THE SURGERY HAD BEEN SCHEDULED FOR (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT WAS RE-IMPLANTED WITH A NEW LEAD ON (B)(6) 2013 AND THE ON-TABLE TESTING GAVE THE PATIENT PARESTHESIA SIMILAR TO THAT EXPERIENCED DURING THE ORIGINAL TRIAL PERIOD. IT WAS STATED THE LEAD WAS THEN CONNECTED TO AN IMPLANTABLE NEUROSTIMULATOR (INS) AND THE PATIENT WAS EDUCATED POST-OPERATIVELY ON OPTIMAL USE. REPORTEDLY, THE PATIENT WAS HAPPY WITH PARAESTHESIA POST-OPERATIVELY AND NO FURTHER PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282201 VECTRIS LEAD STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 977A290

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention