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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem Fracture
Event Date 02/01/2017
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that the patient had been feeling shocks that caused the patient to be unable to talk and barely breathe. The patient experienced such painful shocks that he had to be restrained at the emergency department. The written notes from the physician stated that he thought the "ground pulled off the nerve" without any clarification. The patient had full revision surgery due to the painful stimulation, and the physician later reported that there was an observed lead break during the surgery. However, diagnostics were within normal limits immediately prior to the surgery. The explanted product has not been received to date.

 
Event Description

The generator was received into analysis. The lead was not received from the explanting hospital. The device performed according to functional specifications. Analysis concluded that no abnormal performance or any other type of adverse condition was found.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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 Key6551020
Report Number1644487-2017-03738
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/30/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/08/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2008
Device MODEL Number302-20
Device LOT Number1471
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/05/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/16/2005
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: 05/08/2017 Patient Sequence Number: 1
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