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Event Date 06/18/2013
Event Type  Malfunction  
Manufacturer Narrative

The initial report inadvertently reported the incorrect date.

Event Description

A vns treating nurse reported that the patient who recently had generator replacement on (b)(6) 2013 was recently checked by the nurse for the first time after receiving new medical care. The nurse checked the vns system via diagnostics prior to replacement surgery and in recovery after surgery. All was reportedly okay with the lead, according to the diagnostic readings. The patient was later seen in the local emergency room a couple of days later due to some abdominal pain found to be mostly gas and not related to vns. However, a chest x-ray was performed, and the vns lead was found to be fractured as confirmed by the surgeon. The nurse reported a ¿7. 5 cm gap between the ends of the lead in patient's chest. ¿ the patient was seen on (b)(6) 2013 for post-op vns visit, and she again checked the lead with okay results with lead impedance value at 3561 ohms. The nurse turned off the device on (b)(6) 2013, and reported that the patient may or may not have the lead replaced. No manipulation or trauma was reported to the nurse that may have contributed to the lead fracture. The patient has not reported a change in stimulation perception; however, the patient is developmentally delayed so the nurse is not sure that he would know to report it. Attempts for lead product information have been unsuccessful to date. Ap chest and abdominal x-rays were received by the manufacturer for review. Based on the x-rays images received, there is a gross lead fracture in approximately the middle portion of the lead which is most likely a result of the patient twiddling the lead in the chest. Also, the portion of the lead behind the generator could not be assessed, therefore a lead fracture in that portion of the lead cannot be ruled out. The presence of an additional micro-fracture in the lead also cannot be ruled out.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. Manufacturer reviewed device history records. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Review of lead device history records confirmed all quality tests were passed prior to distribution. Device failure occurred, but did not cause or contribute to a death or serious injury.

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Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key3222463
Report Number1644487-2013-02083
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/18/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/12/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/11/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial