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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 12/08/2014
Event Type  Injury  
Event Description

On 04/29/2016, it was reported that the patient's pain that was first thought to be from the migration (so reported last year) was just recently clarified to be painful stimulation radiating down the jawline with magnet swipes. The patient had not followed up between the report last year and now so this was not known until now. Once the pulse width was adjusted this pain resolved. For the patient's reported migration, he stated there was no reported trauma so they think that the non-absorbable suture may have broken. It was stated that the implanting surgeon does always use non-absorbable sutures. The migration is less painful and more so just an inconvenience as it pops out and moves when she is in different positions. Notes also mention that vns is sticking out. He also noted that the patient's battery was below 50%, so the generator was being replaced prophylactically, though the primary reason for replacement seems to be the migration. Notes state vns moves when she moves left arm and has pain. Clinic notes dated (b)(6) 2016 state that the battery mobility in her chest and its prominence as well as the prominence of the electrode coils in her neck bother her significantly. Inspection of her neck shows fairly prominent positioning of her battery and cervical electrode loops without any skin erosion, erythema, or signs of infection. There is no known cause of the protrusion except normal physiology.

 
Event Description

Implant card was received on 06/13/2016. The patient underwent generator replacement on (b)(6) 2016. The explanted device was discarded and is unavailable for analysis.

 
Event Description

It was reported that the vns patient was referred for surgery due to chest pain and potential generator migration. No known surgical interventions have occurred to date.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key4391038
Report Number1644487-2015-03534
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup
Report Date 12/08/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/07/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date06/30/2012
Device MODEL Number103
Device LOT Number201534
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/13/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/29/2010
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: 01/07/2015 Patient Sequence Number: 1
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