BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3033021 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04540
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 25, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3550-39, EXPLANTED: (B)(6) 2013, PRODUCT TYPE ANCHOR ACCESSORY. (B)(4). ANALYSIS OF LEAD MODEL 3778-60 SERIAL # (B)(4) SHOWED THAT CONDUCTORS #0 THROUGH 6 WERE BROKEN AND STRETCHED 4.4 CM FROM THE DISTAL END DUE TO OVERSTRESS DAMAGE. THE DISTAL END WAS OBSERVED TO BE STRETCHED. THE OUTER INSULATION WAS FOUND TO BE MELTED DUE TO SUSPECTED CAUTERY USE. THE STYLET COIL WAS NOTED AS BROKEN 4.4 CM FROM THE DISTAL END. OPENS CIRCUITS WERE OBSERVED ON CONDUCTORS #0 THROUGH 6 WITH NO SHORT CIRCUITS SEEN. THE ANCHOR ATTACHMENT SITE ON THE LEAD WAS 10 CM AS MEASURED FROM THE DISTAL END. ANALYSIS OF LEAD MODEL 3778-60 SERIAL # (B)(4) SHOWED NO ANOMALIES ANALYSIS OF THE ANCHOR MODEL 3550-39 SHOWED THAT THE TITANIUM INSERT WAS SEPARATED FROM THE SILICONE SLEEVE. THE DEVICE IS INCLUDED IN THE MEDICAL DEVICE SAFETY ALERT, FOR THE MODEL 3550-39 TITAN ANCHOR DUE TO THE POTENTIAL FOR LEAD MIGRATION AS A RESULT OF INSERT SEPARATION WITHIN THE ANCHOR, PHYSICIAN COMMUNICATION (OCTOBER, 2009) Z-0500-2010.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEADS MIGRATED FROM T7 TO L2. ONE OF THE LEADS WAS HOWEVER COMPLETELY FRACTURED. THE REPORTER INDICATED THAT THE PATIENT FELT STIMULATION CHANGE ABOUT 6 WEEKS AFTER IMPLANT. ADDITIONALLY, THE PATIENT EXPERIENCED PAIN AND LESS THAN 50% THERAPY RELIEF. THERE HAD BEEN NO FALLS REPORTED THAT CORRESPONDED TO THE LEAD MIGRATION. BOTH LEADS WERE CONSEQUENTLY REMOVED AND REPLACED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT'S LEADS HAD MIGRATED BACK IN (B)(6) 2013. THE PATIENT STATUS WAS REPORTED AS NO INJURY/NO ADVERSE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136165 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention