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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 07/29/2008
Event Type  Malfunction  
Event Description

It was reported to mfr that the vns pt was seen for a follow up visit, due to worsening depression over the last two weeks, and pain in the chest. The pt has denied any recent trauma, however, the patient mentioned that she mows the lawn, which is on a very steep incline and experienced the chest pain during this activity. Diagnostic testing was performed and revealed high lead impedance, end of service status set to no. The physician subsequently disabled the device. X-rays were sent to manufacturer to review, and a lead discontinuity was observed following the fourth tie-down after the strain relief loop in the neck region. Attempts to obtain additional information for the treating physician have been made, but have been unsuccessful to date.

 
Manufacturer Narrative

Mfr reviewed x-rays of implanted device. Results: review of x-rays by the mfr revealed a gross lead discontinuity. Conclusions: device failure occurred, but did not cause or contribute to a death.

 
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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 Key1172179
Report Number1644487-2008-02232
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/12/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2008
Device MODEL Number302-20
Device LOT Number1188
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/12/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2005
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: 09/11/2008 Patient Sequence Number: 1
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