BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 5870405 · Received August 11, 2016

    Report

    Report Number
    3004209178-2016-16710
    Event Type
    Injury
    Date Received
    August 11, 2016
    Date of Event
    July 18, 2016
    Report Date
    May 31, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3708260, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3998, LOT# V163064, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708260, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID 3998, LOT# V163064, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: EXTENSION. PRODUCT ID 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON 2017-05-09. THE PATIENT REPORTED THAT HER HEALTHCARE PROVIDER (HCP) WAS GOING TO REMOVE THE DEVICE DUE TO NORMAL BATTERY DEPLETION AND THEY WERE GOING TO REPLACE THE ENTIRE SYSTEM. THE PATIENT REPORTED THAT WHEN THEY WERE PERFORMED SURGERY, THEY FOUND THAT THERE WAS TOO MUCH SCAR TISSUE AROUND THE LEADS, SO THEY WERE STUCK TO THE SPINAL CORD AND COULDN¿T BE REMOVED. THE PATIENT REPORTED THAT THE LEADS CAME APART WHEN THEY TRIED TO TAKE THEM OUT AND THEY NEVER PUT ANOTHER BATTERY IN. THE PATIENT REPORTED THAT THEY STOPPED WITH THE REPLACEMENT BECAUSE THEY WERE WORRIED ABOUT FURTHER SPINAL ISSUES. THE PATIENT REPORTED THAT SHE HAD A CERVICAL SPINE INJURY THAT AFFECTED HER HANDS AND IF SHE KNEW THE DEVICE MAY INJURY HER SPINE, SHE WOULD HAVE NEVER DONE THE IMPLANT. NO FURTHER COMPLICATIONS WERE REPORTED. (B)(4).

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE REPORTED THAT HIGH IMPEDANCES WERE OBSERVED INTRA-OPERATIVELY ON (B)(6) 2016 DURING IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY REPLACEMENT [SEE MANUFACTURER¿S REPORT #3004209178-2016-13806 REGARDING INS REPLACEMENT FOR BATTERY DEPLETION/OVERDISCHARGE/END OF SERVICE (EOS)]. WHILE REVIEWING SEVERAL THINGS TO CHECK, THE MANUFACTURER REPRESENTATIVE NOTED THE HEALTHCARE PROFESSIONAL HAD CUT THE OLD EXTENSIONS. NEW EXTENSIONS AND TESTING THE LEAD INTRA-OPERATIVELY WERE DISCUSSED; THE EVENT OUTCOME WAS UNKNOWN AT THAT TIME AS THE MANUFACTURER REPRESENTATIVE HAD HUNG UP THE PHONE AFTER DISCUSSING OPTIONS. THERE WERE NO REPORTED PATIENT SYMPTOMS. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE ON 22-JUL-2016 REPORTED THAT THE MANUFACTURER REPRESENTATIVE¿S NOTES SHOWED IT WAS ALL REMOVED. HOWEVER THE MANUFACTURER REPRESENTATIVE¿S NOTES ALSO INDICATED ¿PRIMARY DEVICE MISSING¿ AND THE PRIMARY DEVICE WAS UNABLE TO BE IMPLANTED; THE NOTES DID NOT INDICATE WHY THE PRIMARY DEVICE WAS NOT ABLE TO BE IMPLANTED. IN ADDITION, THE MANUFACTURER¿S RECORDS NOTED THAT A NEW INS AND NEW EXTENSION WERE OPENED BUT NOT USED. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE ON 24-JUL-2016 INCLUDED THE SERIAL NUMBERS OF THE INS, EXTENSIONS, AND LEADS INVOLVED IN THE HIGH IMPEDANCE ISSUE. IMPEDANCES WERE CHECKED WITH THE NEW INS BATTERY CONNECTED TO THE OLD EXTENSIONS USING DIFFERENT REFERENCES, AND INTRA-OPERATIVE IMPEDANCES WERE >10000 OHMS. THE OLD EXTENSIONS WERE REMOVED, AND THE OLD LEAD¿S IMPEDANCE VALUES WERE WITHIN NORMAL LIMITS. WHEN THE HEALTHCARE PROFESSIONAL PICKED UP THE ENDS OF THE OLD LEAD TO CONNECT THEM TO A NEW EXTENSION, THE ENDS OF THE OLD LEAD FELL APART IN HIS HAND. THE MANUFACTURER REPRESENTATIVE REPORTED THAT WHEN THEY WERE REMOVED, THE MANUFACTURER REPRESENTATIVE WOULD SEND THEM BACK. WHEN ASKED ABOUT WHETHER THE HIGH IMPEDANCES HAD RESOLVED, THE MANUFACTURER REPRESENTATIVE STATED THE LEAD WAS CAPPED AND THE INS AND EXTENSIONS WERE EXPLANTED. THE PATIENT¿S INDICATIONS FOR USE INCLUDED FAILED BACK SURGERY SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522873 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention