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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
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2008
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

The patient saw his neurologist to assess his current epilepsy treatment plan. The patient was referred for vns placement and thus clinic notes were received for review. The patient indicated that they had previously had a pacemaker device that was later determined to be a vns generator. The patient indicated that their generator had been explanted due to pain at some point. X-rays were reviewed and it was confirmed that the lead of the patient's vns lead was still implanted, but the generator was no longer implanted. No additional relevant information has been received to date.

 
Event Description

It was reported through clinic notes that the patient's generator had been taken out. The patient said that he had an allergy to the device, that it didn't work and that it bothered him. The patient also could pick up the lead under the skin; the lead reportedly bothered him and he couldn't straighten his neck. The device history records of the patient's generator was reviewed. The generator passed final quality and functional specification tests prior to final release. No further relevant information has been received to date. The explanted generator has not 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 Key6463667
Report Number1644487-2017-03556
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2005
Device MODEL Number102
Device LOT Number009405
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/20/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/21/2003
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: 04/06/2017 Patient Sequence Number: 1
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