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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 10/01/2012
Event Type  Injury  
Event Description

Clinic notes were received which indicate the patient experienced aspiration and vocal cord paralysis. Notes dated (b)(6) 2012 indicate the patient has a history of a breathing problem, for which the patient is seeing pulmonology. She also episodes of aspiration for which she is see an ear nose throat doctor. Neck ct scan taken on (b)(6) 2012 reported mild asymmetry of the vocal cord, likely due to the known vocal cord paralysis. Notes dated (b)(6) 2013 report that the patient's mother states the patient is going for a throat issue to fix her aspiration. Per the notes, the patient was going to have a surgical procedure to fix her vocal cord and her aspiration. The patient's vns device would likely get turned off for the surgery and be turned on again afterwards. Follow up with the physician found that aspiration is not related to the vns. The vocal cord paralysis has abated, but was diagnosed before the physician saw her. The vns diagnostics indicate the battery is at ifi = no.

 
Event Description

Follow up with the physician found that the patient was diagnosed with the issue prior to seeing this physician and therefore no other information is available. The patient was being seen for possible explant. Surgery is likely, but has not occurred to date.

 
Event Description

The patient was not being seen for possible explant as reported on supplemental report #1. Patient had generator replacement as captured in mfg report #: 1644487-2013-03080.

 
Manufacturer Narrative

The supplemental report #1 inadvertently reported that the patient was being seen for explant. The patient was not being seen for explant.

 
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Brand NamePULSE GEN MODEL 103
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 Key3397096
Report Number1644487-2013-03090
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/11/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/09/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2013
Device MODEL Number103
Device LOT Number201600
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/19/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/23/2005
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: 10/09/2013 Patient Sequence Number: 1
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