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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 LYJ

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CYBERONICS, INC. PULSE GEN MODEL 102 LYJ Back to Search Results
Model Number 102
Event Date 01/01/2007
Event Type  Injury  
Manufacturer Narrative

Ap and lateral x-ray views of neck and chest evaluated by mfr. No anomalies were noted. Device failure is suspected but did not cause or contribute to permanent impairment or death.

 
Event Description

Reporter indicated that the pt was admitted to the hosp for pulmonary problems following a vns replacement. Follow-up with physicians indicated that the pt experienced bradycardia, hypotension, and respiratory failure which required cardiac life support and hospitalization. X-rays reviewed by mfr did not reveal any anomalies. The pt experienced four more instances of bradycardia, hypotension, and a decrease in breathing rate which initially required temporary disablement of the vns with a magnet and finally resulted in programming the device off. It was reported that the pt was hospitalized for all four of these events. The pt's events have resolved since the vns has been turned off. The physicians indicated that "almost with 100% certainty that this is related to vns" and that the device will not be explanted.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceLYJ
Manufacturer (Section F)
CYBERONICS, INC.
houston TX 77058
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
donnie welty, rn, bsn
100 cyberonics blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key829510
MDR Report Key842295
Event Key805128
Report Number1644487-2007-00106
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 03/22/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/20/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number102
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/22/2007
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/20/2007 Patient Sequence Number: 1
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