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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 High impedance
Event Date 09/25/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported by the physician the patient had high impedance. It was later reported that patient had surgery on (b)(6) 2015 due to the high impedance observed. During surgery, the physician removed the vns generator from the pocket, removed the lead pin from the vns generator, wiped the lead pin off, re-inserted the lead pin into the vns generator, and tightened. After the lead pin was re-inserted into the vns generator, multiple diagnostics tests were run, both outside and inside the pocket, which showed the impedance was within the acceptable range.

 
Manufacturer Narrative

Method, results, and conclusions: corrected data: these codes were inadvertently reported incorrectly on the initial mfr. Report.

 
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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 Key5166718
Report Number1644487-2015-06191
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 09/25/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/21/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/08/2016
Device MODEL Number105
Device LOT Number203237
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/10/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/20/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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