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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 05/02/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device was shocking the patient on (b)(6) 2014. The patient¿s device was tested on (b)(4) 2014 and diagnostic results revealed high lead impedance. The patient¿s device was subsequently programmed off. No patient trauma had occurred. Clinic notes were received for the patient¿s office visit on (b)(6) 2014. The patient was last seen on (b)(6) 2014 and there was no evidence of a device malfunction at that time; the patient's device settings were reported to be stable. The notes indicate that the patient¿s device was providing stimulation on an irregular basis and was dysfunctional but did not cause any seizures. The shocking from the device caused coughing and pain. The patient went to the emergency room on 05/02/2014. The magnet was taped over the patient¿s device. The patient felt one pulse of stimulation and the device reportedly stopped responding. The patient did not have any seizures while in the er but did have 2-3 auras. During the office visit, the physician noted a little lateral gaze nystagmus and the patient¿s device showed high impedance. With the magnet removed, the patient jumped whenever his device delivered stimulation which caused coughing and pain. The magnet was taped back over the device and the patient¿s medication was increased. X-rays were provided to the manufacturer for review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The complete lead connector pin insertion could not be assessed due to the poor quality of the images provided. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown. Incomplete lead pin insertion could be a possible cause of the high impedance. However, no definitive conclusions can be made with the images provided. Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2014. The explanted generator has not been returned to date. Review of the available programming and diagnostic history showed normal diagnostic results through 12/28/2010.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. Review of the available programming and diagnostic history. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

 
Event Description

An implant card was received indicating that diagnostic results with the replacement generator and existing lead showed lead impedance within normal limits (impedance value ¿ 2644 ohms).

 
Event Description

Further information was received that the physician recalled that the patient also had continuous stimulation during the time the vns had high impedance. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3838963
Report Number1644487-2014-01379
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2010
Device MODEL Number102
Device LOT Number201269
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/20/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/18/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/29/2014 Patient Sequence Number: 1
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