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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 12/17/2013
Event Type  Malfunction  
Event Description

On (b)(6) 2014, it was reported that the current device was programmed to 3 ma output current, 1. 8 minute off time, and 500 usec pulsewidth. The patient is implanted with a model 103 generator. Review of battery longevity tables show that if the device was programmed to the above output current and pulsewidth at a 33% duty cycle, the device would likely reach ifi status (from beginning of life) in 1. 4 years.

 
Event Description

Additional information was received that the patient is scheduled for generator replacement on (b)(6) 2014. No information has been received indicating whether or not surgery was performed as scheduled.

 
Event Description

Additional information was received that the product analysis was completed on the generator. With the pulse generator case removed and the battery still attached to the pcb, the battery measured 2. 035 volts, indicating a neos condition. However, during a diagnostic test attempt, the battery voltage dropped less than 2. 00 volts, which shows that the battery is depleted (eos) when the device attempts to enter a functional mode. The data in the diagaccumconsumed memory locations revealed that 93. 431% of the battery had been consumed. The post burn-in electrical test results show that the pulse generator module performs according to functional specifications. Other than the noted events, there were no additional performance or any other type of adverse conditions found with the pulse generator.

 
Event Description

Additional information was received that the patient the patient had a generator replacement. The generator was returned to the manufacturer for evaluation. Product analysis is un process but has not been completed.

 
Manufacturer Narrative

Brand name , corrected data: previously submitted mdr indicated that this was unknown; however, the device appears to be a model 103 generator information. Model #, corrected data: previously submitted mdr indicated that the model was unknown; however, this should be 103. This report is being submitted to correct this information. If implanted, give date (mo/day/yr), corrected data: previously submitted mdr indicated that this was unknown; however, the device was originally implanted in 2012. This report is being submitted to correct this information.

 
Event Description

It was reported that the physician was planning on replacing the patient's generator because it's "indicating the need for replacement". The physician indicated that this seems odd. It was later reported that the generator showed ifi and surgery was cancelled. Attempts to obtain additional information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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 Key3658664
Report Number1644487-2014-00587
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/03/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/04/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2013
Device MODEL Number103
Device LOT Number3045
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/23/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/18/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/29/2011
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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