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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR Back to Search Results
Model Number 101
Event Date 10/21/2013
Event Type  Malfunction  
Event Description

On (b)(6) 2013 it was reported that the surgeon called and stated that the patient was unable to get a generator replacement because an incompatible (single-pin instead of dual pin) generator was ordered. The surgery was aborted because the patient would have been under for at least 1. 5 hours if the site had waited for the correct replacement device. No additional information has been provided.

 
Event Description

An implant card was received which indicates that the vns device was explanted on (b)(6) 2013 for "prophylactic" reasons.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 101
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key3474143
Report Number1644487-2013-03511
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/21/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/18/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/29/2002
Device MODEL Number101
Device LOT Number2837
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received01/07/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/22/2001
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: 11/18/2013 Patient Sequence Number: 1
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