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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 09/09/2013
Event Type  Injury  
Event Description

It was reported by the patient's husband that the vns device was "working its way out" and that this was the third time the vns generator had done this. The patient went in for surgery to reposition the device due to the migration and the skin showing signs of potential breakdown. The vns battery was not replaced. Upon follow up, it was found that the generator was not extruding from the skin and there were no causal factors noted in the dictated notes that may have caused it. The nurse's notes indicate the patient's device was implanted in (b)(6) 2013, but over the last few weeks, the patient noticed increased tenderness and redness around the generator area, as well as some irritation. No additional information has been provided.

 
Event Description

It was reported that the patient was scheduled for repositioning surgery. However, it has not been confirmed to date that the surgery occurred.

 
Event Description

Additional information was received stating that the vns patient underwent surgery on (b)(6) 2014 to revise the generator pocket and move the generator from the patient¿s left chest to her right chest.

 
Manufacturer Narrative

Outcomes attributed to adverse event, corrected data: the initial report inadvertently reported this information incorrectly. Implant date, give date, corrected data: the initial report inadvertently reported this information incorrectly.

 
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Brand NamePULSE GEN MODEL 105
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 Key3435628
Report Number1644487-2013-03330
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup,Followup
Report Date 09/30/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/29/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2014
Device MODEL Number105
Device LOT Number3330
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received04/01/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/15/2012
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: 10/29/2013 Patient Sequence Number: 1
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