BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4727041 · Received April 24, 2015

    Report

    Report Number
    3004209178-2015-07855
    Event Type
    Injury
    Date Received
    April 24, 2015
    Date of Event
    April 4, 2015
    Report Date
    April 1, 2016
    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
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS FOR INS (B)(4) REVEALED A HYBRID INTEGRATED CIRCUIT, MUD CRACKING RESIDUE ANOMALY. THE INS WAS RECEIVED WITH NO TELEMETRY AND NO OUTPUT. THE TELEMETRY COULD NOT BE RESTORED AFTER PERFORMING 5 PHYSICIAN MODE RECHARGES. DESTRUCTIVE ANALYSIS OF THE INS WAS PERFORMED. THE INS BATTERY VOLTAGE WAS FOUND TO BE EXTREMELY LOW AT 0.036 VOLTS. ANOTHER PHYSICIAN MODE RECHARGE WAS DONE WHILE MONITORING BATTERY VOLTAGE AND THE INS RECHARGED. THE TRACE REPORT OBTAINED FROM THE INS SHOWED THAT THE INS HAD ONE OVERDISCHARGE. THERE WERE MULTIPLE POR'S RECORDED AND IT APPEARED THAT THE CLOCK HAD RESET ON (B)(6) 2015. BASED ON THE RECHARGE RECORDS ON THE TRACE REPORT IT WAS VERIFIED THAT THE INS HAD KEPT CHARGED, SO THE INS SHOULD NOT HAVE BEEN OVERDISCHARGED. THE INS HYBRID WAS ANALYZED AT THE PRODUCT ANALYSIS LAB AT THE MEDTRONIC TEMPE CAMPUS AND IT WAS DETERMINED THAT THE DEVICE HYBRID HAD QUANTITIES OF THE FOREIGN MATERIAL, REFERRED TO AS MUD CRACKING RESIDUE (MCR) ON SEVERAL OF THE EXPOSED COPPER TRACES OF THE STACKED CHIP SCALE PACKAGE (SCSP). FURTHER OPTICAL INSPECTION REVEALED THAT A WHITE CRYSTALLINE FOREIGN MATERIAL (FM) WAS PRESENT IN THE VICINI TY OF THE TRACES THAT DID NOT EXHIBIT THE WET MCR. IN ADDITION, SEVERAL COPPER TRACE ANOMALIES (CTA) WERE OBSERVED PROTRUDING FROM THE OPPOSITE ENDS OF ADJACENT TRACES WITHOUT MCR; NO ELECTRICAL CTA SHORTS WERE OBSERVED. THE EXACT CORRELATION BETWEEN THE MCR AND CTA TO THE OVERDISCHARGE OF THE INS COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3550-29, PRODUCT TYPE: ACCESSORY. ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    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 THE PATIENT EXPERIENCED ¿LESS THAN 50% THERAPY RELIEF¿ AND ¿NO STIMULATION.¿ THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) REPORTEDLY SHOWED A POWER ON RESET (POR) MESSAGE AND ¿SWITCHED OFF¿ WITH ¿NO STIMULATION¿ BEING DELIVERED TO THE PATIENT. IT WAS NOTED THE INS HAD BEEN CHARGED THE DAY PRIOR TO THE INCIDENT. ON THE DAY PRIOR TO REPORT HOWEVER, THE INS COULD NOT BE CONNECTED TO WITH A PATIENT PROGRAMMER, PHYSICIAN PROGRAMMER, OR RECHARGER. THE POR WAS OBSERVED ON BOTH THE PATIENT PROGRAMMER AND PHYSICIAN PROGRAMMER, BUT NO CODE WAS AVAILABLE. SINCE THE INCIDENT, THE PATIENT WAS ¿WITHOUT ANY THERAPY¿ AND THE PATIENT¿S INS WAS ¿WITHOUT FUNCTION.¿ THE PATIENT¿S INS WAS TO BE REPLACED ON (B)(6) 2015 AS A RESULT OF THE EVENT. THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF REPORT. ADDITIONAL INFORMATION WAS REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271968 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention