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Model Number 102
Event Date 05/09/2012
Event Type  Malfunction  
Event Description

On (b)(6) 2012, product analysis was completed on a generator that had been explanted due end of service. The reported end of service allegation was duplicated in the pa laboratory. The supply current tests did not meet functional specifications; these measurements demonstrate an increased current consumption for the device. The increased current consumption was isolated to a leaky capacitor (c6). With the capacitor substitution for c6, the pulse generator module performed according to functional specifications. The cause for the c6 capacitors increase in leakage could not be determined. Clinic notes from the vns patient's clinical visit on (b)(6) 2012 were received which indicated that since the last visit on (b)(6) 2011, the patient has had ongoing seizures. In (b)(6) 2011, the patient had onset of leg tremors that were initially thought to represent clonus, but these progressed to involve his arms and legs and sometimes his face. The patient has had no change in consciousness, but does get agitated during these spell; duration 20-60min. Otherwise, the patient has an average of one seizure every 2 weeks lasting 5-10minutes, described as facial grimacing/twitching and myoclonic jerks. Swiping the vns magnet is no longer effective in stopping/reducing the duration of the patient's seizures. The patient takes tranxene 3. 75mg tablet as needed with increased seizures. The patient receives vns stimulation that is programmed to deliver output=1. 5ma/on time=30sec/off time=1. 8min/pulse width=500usec/frequency=30hz/magnet on time=1. 75ma/magnet pulse width=500usec/magnet on time=60sec. The patient tolerates these without any adverse effects. The patient was noted to be more agitated and has a baclofen pump. There have been no changes in his medications or environmental changes. The physician noted that he attempted to interrogate the patient's vns on this visit but was unable to do so with two different systems. The patient was noted to continue to have breakthrough seizures several times a month, but overall his seizure control has been fairly stable. The vns was stated to be at end of service and was not delivering any stimulation. The patient's mother feels the vns has been efficacious for the patient's seizure control and wanted the vns replaced. The patient was again noted to be more agitated over the past few months for unclear reasons but the physician stated that it is possible that his mood was improved with vns and since he is no longer receiving any stimulation, it has deteriorated.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

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Type of DeviceGENERATOR
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
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 Key2828542
Report Number1644487-2012-02946
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/17/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/12/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2007
Device MODEL Number102
Device LOT Number014097
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/23/2012
Event Location Other
Date Manufacturer Received10/17/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/04/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial