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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

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CYBERONICS, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 05/04/2011
Event Type  Malfunction  
Event Description

During review of programming and diagnostic history, it was observed that the vns patient¿s device was tested during an office visit on (b)(6) 2011 and system diagnostic results revealed high impedance (dc dc ¿ 7). Clinic notes from the patient¿s office visit on (b)(6) 2014 indicate that the patient was having as many as 10 seizures per day. It was noted that the patient¿s magnet was not aborting the patient¿s seizures. A battery life calculation using the available programming history show 0 years remaining until eri = yes. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Event Description

Analysis of the returned generator and lead was completed. The end of service condition of the explanted generator was determined to be the result of normal battery depletion. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Discontinuity of both positive and negative quadfilar coils in the body region of the returned lead portion was confirmed where abraded openings were observed on the outer and both inner silicone tubes and tie down location. The abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.

 
Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The patient¿s explant device could not be interrogated which was suspected to be due to an end of service condition of the device. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

 
Manufacturer Narrative

Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death.

 
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Brand NameBIPOL LEAD MODEL 300
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key4443052
Report Number1644487-2015-03686
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/29/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2003
Device MODEL Number300-20
Device LOT Number4309
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/16/2015
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received04/08/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/04/2001
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: 01/22/2015 Patient Sequence Number: 1
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