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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
Event Date 10/22/2009
Event Type  Malfunction  
Event Description

Initial rptr indicated that the pt was in clinic with severe pain in their neck area. The pt had been reporting shortness of breath and painful stimulation that had occurred sometime in the last week. The pt had not had any trauma or injury to the area. The pt reported that their stimulation feels much stronger now than it previously had, although no settings changes had been made. X-rays were reviewed at the mfr. In the ap view, an acute angle was observed in the lead body near one of the tie-downs. It cannot be determined if this acute angle is contributing to the dcdc = 0. A lead discontinuity cannot be ruled out. No other obvious anomalies were observed in the portions of the lead visualized that could be contributing to the reported dcdc = 0 results. At this time, no surgical plans have been made for the pt's vns. Their vns was programmed off on (b) (6) 2009.

 
Manufacturer Narrative

Mfr reviewed x-rays of implanted device. X-rays reviewed by mfr, no gross lead break seen. An area noted with a possible acute angle lead break cannot be ruled out.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1547258
Report Number1644487-2009-02617
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 10/22/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/20/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2009
Device MODEL Number302-20
Device LOT Number200340
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/22/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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