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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 304

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CYBERONICS INC LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 11/06/2014
Event Type  Malfunction  
Event Description

On (b)(6) 2014 it was reported that the patient was experiencing shocking pain with stimulation and was in the emergency room. The patient was admitted to the hospital and was still there the next day, though the use of the magnet did stop the shocking. It was noted that the patient¿s treating neurologist had retired. It was reported on (b)(6) 2014 that the patient has high lead impedance. The patient said that this may have occurred because he took a fall and hit his chin pretty hard about a month prior. Although surgery is likely, it has not occurred to date.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death.

 
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Brand NameLEAD MODEL 304
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 Key4285947
Report Number1644487-2014-03170
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 11/06/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/01/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2015
Device MODEL Number304-20
Device LOT Number2900
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/06/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/03/2011
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: 12/01/2014 Patient Sequence Number: 1
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