BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 6388705 · Received March 8, 2017

    Report

    Report Number
    3004209178-2017-05246
    Event Type
    Injury
    Date Received
    March 8, 2017
    Date of Event
    April 6, 2015
    Report Date
    May 3, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 977A290 LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2013 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 977A290 LOT# SERIAL# (B)(4). IMPLANTED: (B)(6) 2013 EXPLANTED: PRODUCT TYPE LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    NOTE THAT SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE : 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. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 977A290 LOT# SERIAL# (B)(4) IMPLANTED:(B)(6) 2013 EXPLANTED: 2016-APR-06 PRODUCT TYPE LEAD PRODUCT ID 977A290 LOT# SERIAL# (B)(4) IMPLANTED: (B)(6)2013 EXPLANTED: (B)(6)2016 PRODUCT TYPE LEAD IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL OF A CLINICAL STUDY REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN, OTHER CHRONIC/INTRACT PAIN OF THE TRUNK/LIMBS AND CHRONIC LOW BACK PAIN. ON (B)(6) 2015, THE PATIENT REPORTED THE LEADS WERE REMOVED DURING A RECENT SURGERY. IT WAS REPORTED THAT THE PATIENT HAD A SCREW FROM A FUSION REMOVED AND, AT THAT TIME, THE SPINE SURGEON ALSO REMOVED THE LEADS. THE THERAPY WAS SUSPENDED ON (B)(6) 2015. THE INS REMAINED IN THE PATIENT. A DEVICE DIAGNOSIS OF A NON-FUNCTIONAL SYSTEM AND CLINICAL DIAGNOSIS OF INCREASED PAIN WAS REPORTED. THE PATIENT DESIRED REPLACEMENT OF THE LEADS. ADDITIONAL INFORMATION FROM THE HEALTHCARE PROFESSIONAL OF THE CLINICAL STUDY REPORTED THAT REPLACEMENT OF THE TWO EPIDURAL ELECTRODES WAS ATTEMPTED ON (B)(6) 2016. HOWEVER, THE PHYSICIAN NOTED EXCESSIVE SCARING IN THE EPIDURAL SPACE DURING THE SURGERY. THE PLACEMENT OF THE ELECTRODES WAS ABORTED AND THE INS WAS EXPLANTED. THE EVENT RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE DEVICE DIAGNOSIS WAS NOT APPLICABLE. THE CLINICAL DIAGNOSIS WAS INCREASED PAIN. INTERVENTIONS INCLUDED SUSPENDING THERAPY. INTERVENTIONS INCLUDED SURGICAL INTERVENTION SPECIFICALLY THERE WAS AN ATTEMPTED LEAD REPLACEMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HCP. IT WAS CLARIFIED THAT THE ENTIRE SYSTEM WAS EXPLANTED AND NOT REPLACED ON (B)(6)2016. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169154 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention