BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3840975 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09906
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 9, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS DETERMINED TO LIKELY HAVE BEEN A LEAD FRACTURE. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT NEEDED A LEAD REVISION DUE TO MIGRATION. IT WAS NOTED THE REVISION WAS SCHEDULED FOR NEXT WEEK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS SICK AND THEY CANCELLED SURGERY. IT WAS NOTED THE SURGERY WAS RESCHEDULED TO (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A LEAD REVISION OR REPLACEMENT WAS PERFORMED AND THE POCKET WAS NOT CHANGED. IT WAS NOTED THAT THE PATIENT WAS GETTING GOOD RELIEF SINCE SURGERY. IT WAS NOTED THAT THE PATIENT EXPERIENCED A STINGING SENSATION AT THE BATTERY REGARDLESS OF WHETHER THE STIMULATION WAS ON OR OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PINCHING AND BURNING AT THE BATTERY SITE WHEN STIMULATION WAS ON. IT WAS NOTED THAT THE HEALTHCARE PROFESSIONAL (HCP-PHYSICIAN AND NURSE PRACTITIONER) WOULD CALL THE PATIENT. IT WAS REPORTED THAT IMPEDANCE TESTING AND REPROGRAMMING WERE PERFORMED. IT WAS STATED THAT THE ISSUE WAS NOT RESOLVED ON THE DAY OF THIS REPORT AND THE CAUSE OF THE ISSUE HAD NOT BEEN DETERMINED. IT WAS STATED THAT IT WAS UNKNOWN IF THE LEADS WERE A PROBLEM YET. IT WAS STATED THAT THE PATIENT HAD BURNING SENSATION AND PAIN AT THE DEVICE POCKET. THE PATIENT STATUS WAS LISTED AS ALIVE- NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT SAW THE HCP YESTERDAY AND X-RAYS SHOWED LEAD MIGRATION. IT WAS REPORTED THAT THE PATIENT WOULD BE SCHEDULED FOR REVISION IN THE FUTURE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REVISION WAS SCHEDULED FOR (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SEEN ON (B)(6) 2014 IN FOLLOW UP. NO REPORTS OF THE STINGING, IT HAD RESOLVED. IT WAS UNKNOWN HOW OR WHY IT WAS OCCURRING PREVIOUSLY. THE PATIENT HAD GOOD COVERAGE OF THE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318403 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00022 YR Required Intervention