BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3944681 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-13247
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    June 26, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT FOR FOLLOW-UP WAS COMPLETED. THE INS REMAINS IMPLANTED. THE EVENT DID NOT ALLEGE A POTENTIAL MANUFACTURING ISSUE; THEREFORE, A DHR REVIEW WAS NOT REQUIRED FOR THE INS. THE EVENT WAS REVIEWED FOR EXISTING INVESTIGATIONS AND NONE APPLIED. THE EVENT WAS REVIEWED FOR KNOWN INHERENT RISKS LISTED IN PRODUCT LABELING AND EVENT APPLIES TO KNOWN EVENT TREND PAIN BECAUSE THE PATIENT WAS EXPERIENCING PAIN ASSOCIATED WITH A LACK OF COVERAGE. CHEST WALL STIMULATION SENSATION WAS NOT APPLIED SINCE THE STIMULATION DID NOT OCCUR ION THE CHEST WALL REVIEWED FOR ESCALATION TO NCET AND ESCALATION WAS NOT REQUIRED. EVENT IS INCLUDED IN MONITORING FOR KNOWN INHERENT RISKS AS DISCLOSED IN PRODUCT LABELING. THE INVESTIGATION OF THE INS IS INCONCLUSIVE BECAUSE REVISION SURGERY HAS NOT YET BEEN SCHEDULED, SO THE EVENT REMAINS ONGOING. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A290, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 977A290, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    REVIEW OF THIS MDR AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD STIMULATION IN THE WRONG LOCATION. IT WAS NOTED THAT COMPATIBILITY GUIDELINES WERE REQUESTED FOR MRI. IT WAS REPORTED THE PATIENT CURRENTLY HAD A CERVICAL IMPLANT AND HE WAS NOT GETTING THE COVERAGE HE NEEDED IN THE SCAPULA AREA. IT WAS NOTED THAT THE MANUFACTURER¿S REPRESENTATIVE WAS IN A RUSH TO ATTEND ANOTHER CASE. IT WAS FURTHER REPORTED IN FOLLOW UP THAT THE PATIENT HAD AN EPIDURAL PLACED NEUROSTIMULATOR IN HIS CERVICAL SPINE FOR PAIN IN HIS RIGHT SHOULDER BLADE. IT WAS STATED HE WAS GETTING STIMULATION FROM THE TOPS OF HIS SHOULDERS DOWN TO HIS HANDS. IT WAS STATED HE HAD NOT BEEN ABLE TO GET RELIEF IN HIS POSTERIOR SCAPULA. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT WAS STILL NOT RECEIVING EFFECTIVE THERAPY. IT WAS FURTHER REPORTED THAT THE PATIENT STILL HAD COVERAGE IN THE ARMS AND HANDS. IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL (HCP) WAS CONSIDERING MOVING THE LEADS. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE HEALTHCARE PROFESSIONAL WAS STILL ASSESSING WHAT TO DO FOR THE PATIENT. A COURSE OF ACTION WAS STILL UNDETERMINED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REVISION HAD NOT BEEN SCHEDULED YET TO THE KNOWLEDGE OF THE MANUFACTURER'S REPRESENTATIVE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE 50% OR GREATER SYMPTOM REDUCTION. IT WAS NOTED THAT THE EVENT INVOLVED THE INS, LEAD, PROGRAMMER AND RECHARGER. IT WAS STATED THAT THE CAUSE OF THE EVENT WAS DETERMINED AND WAS NOT DEVICE RELATED. IT WAS REPORTED THAT A LEAD REPLACEMENT WAS PERFORMED AND THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. IT WAS NOTED THAT THE PATIENT WOULD BE HAVING ¿BI-PASS¿ SURGERY THAT WAS UNRELATED TO THE SPINAL CORD STIMULATOR (SCS) PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS HAVING A LEAD REVISION TODAY DUE TO COVERAGE NEEDS NOT BEING MET. A HEALTHCARE PROVIDER (HCP) HAD RETRIALED THE PATIENT AND FOUND THE CORRECT LOCATION TO PLACE THE LEAD. THE HCP WAS GOING TO PULL DOWN ONE OF THE ORIGINAL LEAD TO COVER CURRENT PAIN AND INSERT A THIRD LEAD TO COVER AREA THAT WAS NOT BEING COVERED. THE OTHER ORIGINAL LEAD WAS GOING TO BE DISCONNECTED AND ABANDONED INSITU. THE HCP THOUGHT THEY HAD GOOD COVERAGE AT THE TIME OF IMPLANT, BUT FOLLOWING SURGERY AND REPROGRAMMING, IT WAS DETERMINED THAT THEY WERE NOT CAPTURING THE CORRECT AREA. IT WAS NOTED THAT THE LEADS WERE LOCATED IN THE CERVICAL REGION. IT WAS LATER REPORTED THAT THE PATIENT HAD NOT BEEN SCHEDULED FOR A LEAD REVISION YET. HE WAS GETTING STIMULATION IN BOTH HANDS AS OPPOSED TO THE RIGHT BACK SHOULDER BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422813 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention