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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 04/15/2013
Event Type  Malfunction  
Event Description

The surgeon reported that a non-absorbable suture used to secure the generator to fascia during implantation of the device on (b)(6) 2012.

 
Event Description

It was initially reported that the patient reported to the neurologist that her generator migrated to the left axillary area. The neurologist¿s office reported on (b)(6) 2013 that they were referring the patient back to the implanting surgeon as they suspect that the lead has come disconnected from the generator, and the patient was having an increase in seizures since the early part of the prior week. Additionally, the neurologist¿s office was unable to interrogate the generator on (b)(6) 2013. It was unknown by the nurse at the neurologist¿s office if patient manipulation or trauma occur that is believed to have caused/contributed to the generator migration. The patient later reported on (b)(6) 2013 that she is considering having her device removed. She reported that three days after implanted, the patient began to experience frequent chest pains, shortness of breath, and difficulty speaking; these events are captured in mfg report number: 1644487-2013-01474. She also reported experiencing hot flashes. She reported that her seizures have reduced from daily to 5 times in the last year. The last vns dosing adjustment was (b)(6) 2013, in which she reported that the neurologist turned the vns settings up. However, this has not been confirmed by the neurologist to date. Attempts for information from the neurologist have been unsuccessful. Additionally, attempts to the surgeon regarding type of suture used to secure the generator to the fascia during implant surgery have been unsuccessful to date. Although surgery is likely, it has not occurred to date.

 
Manufacturer Narrative

Review of manufacturing records performed. Review of the generator manufacturing records confirmed all quality tests were passed prior to distribution.

 
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Brand NamePULSE GEN MODEL 102
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3123691
Report Number1644487-2013-01510
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/26/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/22/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2013
Device MODEL Number102
Device LOT Number3190
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/24/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/06/2011
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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