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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
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2014
Event Type  Malfunction  
Event Description

An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. Further follow-up revealed that the patient underwent surgery for patient comfort and not to preclude a serious injury. Patient manipulation or trauma is not believed to have caused or contributed to the lead discontinuity. The patient¿s pain was occurring with stimulation and due to lead discontinuity. The explanted products have not been returned to date.

 
Event Description

The patient¿s pain was occurring with stimulation and due to lead discontinuity. The lead discontinuity is likely due to a short circuit situation (dcdc code = 0).

 
Event Description

Surgical notes dated (b)(6) 2014 indicated that the vns was malfunctioning and that the patient underwent generator and lead replacement.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death. Adverse event and/or product problem; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain. Brand name; corrected data: additional information indicates that the suspect device is the lead. Type of device, name; corrected data: additional information indicates that the suspect device is the lead. Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the lead. Type of reportable event; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain. Device manufacture date; corrected data: additional information indicates that the suspect device is the lead.

 
Event Description

It was reported that the vns patient was experiencing very painful side-effects from vns. Further follow-up with the patient revealed that the patient was experiencing pain on the left side of her neck that radiated up to her temple. This mostly occurred through the patient¿s jaw and roof of her mouth causing headaches. The patient was most uncomfortable at night and when she was lying down. The patient later reported that the pain was getting worse and that she was feeling sick and panicking. The patient¿s device was eventually programmed off on (b)(6) 2014 despite it being effective in treating the patient¿s depression. The patient was referred for generator and lead replacement surgery due to severe headaches and neck spasms. The patient¿s normal mode output current was programmed off and system diagnostic results showed normal device function. No known interventions have occurred to date.

 
Manufacturer Narrative

 
Manufacturer Narrative

Describe event or problem, corrected data: this information (spasms, fatigue, nausea) was inadvertently not included in the initial mfr. Report. Describe event or problem, corrected data: this information (pain, coughing) was inadvertently not included in the mfr. Supplement report #3. Additional manufacturer narrative, corrected data: mfr. Supplemental report #2 should have included the description of the corrected data as "describe event or problem, corrected: this information was inadvertently not included in the initial mfr. Report. ".

 
Event Description

It was reported that the patient experienced abdomen and chest spasms, fatigue and nausea. The patient experienced pain and coughing at the time of device interrogation.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key3808957
Report Number1644487-2014-01246
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/17/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/13/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2008
Device MODEL Number302-20
Device LOT Number1012
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/30/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/08/2005
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: 05/13/2014 Patient Sequence Number: 1
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