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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/15/2015
Event Type  Injury  
Event Description

It was reported that the vns patient was having unspecified cardiac issues and was referred for surgery to explant the device. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

 
Event Description

The patient's device was explanted on (b)(6) 2015. The explanted device has not been returned to date.

 
Manufacturer Narrative

Date of explant; corrected data: the previously submitted mdr inadvertently provided the wrong explant date of the device.

 
Event Description

Additional information was received which indicated that the generator and lead were explanted on (b)(6) 2015. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. The nurse that initially reported the event provided additional information. The "heart problems" started on (b)(6) 2015. The patient had cough, shortness of breath, and chest tightness. Due to the chest tightness, she went to the er and was diagnoses with hyperkalemia, which she interpreted as a heart attack. This was not related to vns and no interventions were taken. The nurse also indicated that there was no actual arrhythmia. She stated that she does not think vns was causing any cardiac issues. She is not sure why the patient had pain, but the pain continued with the device off. The patient still complains of pain with the device removed.

 
Event Description

Product analysis was completed for the lead. There was no evidence to suggest an anomaly with the returned portion of the device. Since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Product analysis was completed for the generator. There were no performance conditions found with the pulse generator. There was a device issue found which was unrelated to the reported adverse event. This issue will be reported in mfr. Report # 1644487-2015-05884.

 
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Brand NamePULSE GEN MODEL 105
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 Key4876988
Report Number1644487-2015-05052
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/05/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/29/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2015
Device MODEL Number105
Device LOT Number202801
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/10/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/28/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/17/2014
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: 06/29/2015 Patient Sequence Number: 1
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