BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4240162 · Received November 10, 2014

    Report

    Report Number
    3004209178-2014-21217
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 97792, LOT# N475247, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT¿S HEALTH CARE PROVIDER (HCP) REPORTED A MONTH AND A HALF LATER THAT THE PATIENT BECAME A PARAPLEGIC POST-OP. THE LEAD WAS INVOLVED IN THE EVENT. A MYELOGRAM, CT, AND MRI WAS PERFORMED. IT WAS CLARIFIED THAT THE PATIENT HAD THORACIC SPINAL STENOSIS, NOT EPIDURAL HEMATOMA. THERE WAS NOT A 50% OR GREATER SYMPTOM REDUCTION. THE PATIENT HAS NOT RECOVERED, SYMPTOMS/ISSUE WAS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD AN EPIDURAL HEMATOMA AND THAT THEIR ENTIRE IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM WAS REMOVED. THE PATIENT UNDERWENT A THREE LEVEL DECOMPRESSION/LAMINECTOMY AND WAS HOSPITALIZED (AND STILL HOSPITALIZED AS OF (B)(6) 2014 PER FOLLOW UP) ON THE IN-PATIENT REHAB FLOOR. IT WAS NOTED THAT THE EVENT ISSUE WAS NOT DEVICE RELATED BUT WAS RELATED TO THE IMPLANT PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS PARALYZED (AT THE LEAD LOCATION) AND WAS BEING MANAGED BY A NEUROSURGEON. THERE WERE NO FURTHER DETAILS, INTERVENTIONS OR OUTCOME REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED, IT CAUSED A SPINAL CORD STROKE AND THE NEXT DAY THE INS WAS TAKEN OUT, ON (B)(6) 2014. THE PATIENT WAS PARALYZED AT THE TIME OF THE REPORT BECAUSE OF THE PROCEDURE. THEY WERE NOT LOOKING TO PERUSE THE HEALTHCARE PROVIDER (HCP) FOR INJURY. THEY WORKED WITH A MANUFACTURER REPRESENTATIVE (REP) BUT COULDN¿T REMEMBER THEIR NAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723668 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB MEDTRONIC PUERTO RICO OPERATIONS CO. 97712

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R| S