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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
Event Date 11/01/2014
Event Type  Injury  
Manufacturer Narrative

 
Event Description

On (b)(6) 2015 the physician reported that the patient is unable to tolerate an output current of 0. 5ma and therefore diagnostics have not been performed.

 
Event Description

On (b)(6) 2015 it was reported that the patient underwent explant of the vns device due to painful stimulation and coughing. It was noted that the patient¿s settings could never be increased due to these adverse events and so the patient did not have efficacy with the vns. The device was disabled on (b)(6) 2014 and then explanted on (b)(6) 2014. It was reported that the hospital no longer returns explanted products and therefore the explanted generator could not be returned for product analysis. Additional information was requested from the physician but no further information was received.

 
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Brand NamePULSE GEN MODEL 102
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 Key4475189
Report Number1644487-2015-03730
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 01/16/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date08/31/2013
Device MODEL Number102
Device LOT Number201870
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/13/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/07/2011
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: 02/02/2015 Patient Sequence Number: 1
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