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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

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CYBERONICS - HOUSTON LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 09/01/2015
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that a patient had full revision surgery due to an unknown reason. Further information was received indicating that the full revision was done because the patient experienced pain in the left upper extremity, which, according to the surgeon, was due to the placement of the original lead. The cause of the pain was due to lead migration. However, the cause of the migration was unknown. The physician reported that the surgery was done for patient comfort and to preclude a serious injury. The explanted generator and lead were received on 08/10/2016. Analysis of the lead identified no anomalies. Analysis of the generator also identified no anomalies. No further relevant information has been received to date.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5962153
Report Number1644487-2016-02130
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/25/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/20/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2008
Device MODEL Number302-20
Device LOT Number1136
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/10/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/25/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/10/2005
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: 09/20/2016 Patient Sequence Number: 1
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