BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3900428 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-12204
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR INFORMED THE MANUFACTURER REPRESENTATIVE THAT ¿EARLIER IN THE WEEK¿ THEY HAD REMOVED LEADS FROM A PATIENT THAT THEY THOUGHT WERE THE LEADS OF THE MANUFACTURER. IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM WAS REMOVED ON (B)(6) 2014. IT WAS NOTED THAT ALL SYSTEM COMPONENTS WERE REMOVED ON (B)(6) 2014. IT WAS NOTED THAT THE LEADS WERE PLACED CERVICALLY AND HAD BROKEN PRIOR TO THE REMOVAL. DURING THE LEAD REMOVAL ONE CONTACT FROM EACH LEAD REMAINED IMPLANTED. ONE WAS AT C1 AND THE OTHER WAS AT C4. THE MANUFACTURER REPRESENTATIVE WAS NOT SURE WHEN THE LEADS BROKE. THE DOCTOR TOLD THE MANUFACTURER REPRESENTATIVE THEY TOOK PICTURES AND THE LEADS WERE BROKEN PRIOR TO REMOVAL. IT WAS NOTED THAT THE PATIENT WAS NOT RECEIVING ADEQUATE THERAPY AND THIS WAS THE REASON THE LEADS WERE REMOVED. IT WAS NOTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE DOCTOR DID NOT KNOW IF THE INS WAS FOR HEADACHES AND DID NOT KNOW WHY THE LEADS WERE PLACED ¿SO HIGH.¿ THE MANUFACTURER REPRESENTATIVE DID NOT KNOW WHEN THE PATIENT STOPPED RECEIVING ADEQUATE THERAPY. THE DOCTOR WANTED TO KNOW IF THE PATIENT WOULD STILL BE ELIGIBLE FOR AN MRI. THE MANUFACTURER REPRESENTATIVE DID NOT KNOW THE AREA THEY WANTED TO SCAN WITH THE MRI. IT WAS LATER REPORTED THE DOCTOR INFORMED THE MANUFACTURER REPRESENTATIVE THAT THE PATIENT ¿JUST WANTED EVERYTHING REMOVED.¿ THE MANUFACTURER REPRESENTATIVE DID NOT RECALL IF THE BATTERY WAS END OF SERVICE (EOS) JUST THAT THE PATIENT WAS NOT RECEIVING THERAPY AND NO LONGER WANTED THE DEVICE IMPLANTED. IT WAS NOT KNOWN HOW LONG THE PATIENT WENT WITHOUT RECEIVING PROPER STIMULATION THERAPY. THE MANUFACTURER REPRESENTATIVE FOUND OUT ABOUT THE SURGERY ON (B)(6) 2014 THE ON THE DATE OF REPORT. THERE WAS NO A MANUFACTURER REPRESENTATIVE AT THE SURGERY AND DO NOT HAVE ANY OF THE DEVICES TO RETURN. THE MANUFACTURER REPRESENTATIVE¿S UNDERSTANDING WAS IT WAS EITHER THE 0, 1 OR 2 ELECTRODE OF THE 0-7 LEAD THAT HAD BROKEN AND REMAINED AT C1. ON THE 8-15 LEAD THE MANUFACTURER REPRESENTATIVE BELIEVED IT WAS EITHER THE 13, 14 OR 15 ELECTRODE THAT WAS BROKEN AND REMAINED AT C-4 LEVEL. IT WAS NOTED THAT THE DOCTOR ASKED THE MANUFACTURER REPRESENTATIVE IF IT WAS SAFE TO HAVE AN MRI WITH THE TWO REMAINING LEAD CONTACTS. THE MANUFACTURER REPRESENTATIVE HAD NOT SEEN THE PATIENT POSTOPERATIVELY OR RECEIVED ANY KNEW CALLS REGARDING THE SITUATION. THE MANUFACTURER REPRESENTATIVE ATTACHED PICTURES THAT THE DOCTOR SHARED WITH THE PATIENT CONCERNING THE PREVIOUSLY REPORTED INFORMATION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT COMPATIBILITY GUIDELINES WERE BEING REQUESTED FOR AN MRI. INFORMATION ABOUT BROKEN ELECTRODES THAT WERE LEFT IN THE PATIENT'S BODY WAS REVIEWED. THE AREA TO BE SCANNED WAS A FULL BODY SCAN. THE REASON FOR THE SCAN WAS UNKNOWN. NO APPOINTMENT HAD BEEN SCHEDULED YET.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE DID NOT KNOW THE PATIENT OUTCOME. PER THE MANUFACTURER REPRESENTATIVE UNDERSTANDING IT WAS RECOVERED WITHOUT SEQUELAE. THE MANUFACTURER REPRESENTATIVE HAD NOT RECEIVED ANY FURTHER CALLS REGARDING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377019 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Other