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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 01/09/2015
Event Type  Malfunction  
Event Description

Product analysis for the patient's lead was completed and approved on 2/9/2015. A break was identified at the end of the positive and the negative lead coils. Scanning electron microscopy images of the positive and the negative lead coils show that pitting or electro¿etching conditions have occurred on the coils¿ ends. However, due to metal dissolution the fracture mechanism cannot be determined. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Product analysis for the m105 generator was completed and approved on 2/18/2015: in the (b)(6), the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

 
Event Description

It was reported that during generator replacement surgery on (b)(6) 2015, the vns patient¿s generator site had pus and was subsequently washed out. Both the generator and lead were explanted due to infection. The patient has not been re-implanted to date. Follow-up revealed that the patient¿s device showed a high impedance condition prior to explant. Attempts for additional relevant information have been unsuccessful to date. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

 
Event Description

Implant card received on 07/02/2015 states that patient had a re-implant surgery on (b)(6) 2015. The original explant had occurred on (b)(6) 2015 with no replacement at that time. The new lead and generator were placed on (b)(6) 2015.

 
Manufacturer Narrative

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 or serious injury.

 
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Brand NameLEAD MODEL 304
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 Key4490139
Report Number1644487-2015-03763
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 01/12/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/06/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2014
Device MODEL Number304-20
Device LOT Number2792
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/15/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/02/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/02/2010
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: 02/06/2015 Patient Sequence Number: 1
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