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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 07/02/2013
Event Type  Malfunction  
Event Description

It was reported that the patient was in the operating room under anesthesia for prophylactic generator replacement, it was observed that the replacement model 104 device was at ifi (intensified-follow-up condition) with ifi=yes observed during when pre-operatively, the device was at 100% battery capacity. Therefore, the model 104 replacement device was also explanted, and not used. Troubleshooting was performed during surgery. The company representative observed the surgeon use electrocautery during the original explant, but was unable to verify if it was used with the replacement model 104 device was placed. The surgeon reported that he was not sure if he used electrocautery in the vicinity of the replacement device, as surgery is a complicated process. No other issues were reported from the surgery. The patient was implanted with another generator successfully. The unused generator was returned to the manufacturer for analysis. However, product analysis has not been completed to date. Additionally, a copy of the programming/diagnostic data from the surgery was copied by the company representative, but the data has not been uploaded/reviewed to date. If electrocautery was used in the vicinity of the replacement generator, the asic latch-up condition may have occurred where the errrant end of service conditions may be due to the asic remaining in a trickle charge state when an undeliverable output current is programmed.

 
Manufacturer Narrative

 
Event Description

Analysis of the generator was completed on (b)(6) 2013. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Burn marks on the generator case suggest it was exposed to high energy such as an electro-cautery system during the attempted implant. Results of diagnostic testing indicated the device was operating properly. Following a re-enable of the generator output, electrical test results showed that the pulse generator performed according to functional specifications.

 
Manufacturer Narrative

End of service message seen upon interrogation of the pulse generator.

 
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Brand NamePULSE GEN MODEL 104
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 Key3248849
Report Number1644487-2013-02245
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/26/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2015
Device MODEL Number104
Device LOT Number202466
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/15/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/12/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2013
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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