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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 Type  Malfunction  
Event Description

It was reported that the vns patient was referred for surgery due to a depleted battery and lead break. It is unclear how the lead break was determined, but it was attributed to the patient¿s recent mammogram that damaged her device. The date of the mammogram is unknown. The patient presented with pain in her left chest and neck on (b)(6) 2014 following the issue with the mammogram. The patient did not experience any pain related to vns prior to the mammogram. The patient¿s device was disabled and the patient did not have symptoms since the device disablement. The patient stated that the generator had migrated further down towards the axilla aggravating the incision scars. The physician noted that the incision sites appeared normal. The patient¿s device did not show any issues with the device. An implant card was received indicating that the patient underwent generator and lead replacement surgery on (b)(6) 2014 due damage from the mammogram. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

 
Event Description

Analysis of the returned generator and lead was completed. There were no anomalies found with the pulse generator. There were no observed product-related anomalies with the single returned lead portion. Radiographic examination of the connector pin (negative coil) and ring (positive coil) shows the ends of the coils at the crimp locations. Although not conclusive, it is believed that the coils were torn at crimp locations most likely at explant.

 
Manufacturer Narrative

 
Event Description

Information received on 05/17/2016 for file (b)(4) regarding the patient's post-op nerve damage, states that the patient did have a broken lead after mammogram and underwent a full replacement because of it which was previously reported.

 
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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 Key4168428
Report Number1644487-2014-02679
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 09/18/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/14/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2009
Device MODEL Number302-20
Device LOT Number200364
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/07/2014
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/17/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/13/2006
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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