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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
Device Problem Insufficient Information
Event Date 07/09/2015
Event Type  Injury  
Manufacturer Narrative

Suspect device udi: (b)(4).

 
Event Description

It was reported that the patient acquired an infection, which was first observed by the physician on (b)(6) 2015. The infection was reported to have started in the chest incision and followed the lead up to the neck site. Patient underwent explant of vns system on (b)(6) 2015 as planned. No patient involvement was suspected. A culture was taken but the results were not available. Review of manufacturing records confirmed that both the generator and lead were sterilized prior to distribution.

 
Event Description

An image was received showing flushing and puffiness around the generator pocket incision site. Some puffiness was also visible around the neck incision site. Notes from the surgery were also received stating that the patient developed some redness near the incision and some drainage that appears to be infected. The surgeon found some serosanguineous fluid , which was cultured and then removed the generator from pocket. The surgeon also removed the lead and was able to dissect the lead but noted that there was significant amount of scarring and inflammation in the sternoclaoimastoid muscle.

 
Event Description

Additional information was received that the patient is still fighting (b)(6) infection and that the physician recommended explant of the lead, which was not previously removed. The initial infection was reported to have started about a week after implant.

 
Event Description

Patient underwent lead removal surgery on (b)(6) 2016 and the surgeon removed the two electrode sets and the anchor tether. During the surgery, the surgeon noted that there was evidence of left vagus nerve injury that resulted in hoarseness and coughing. The surgeon's impression was that someone pulled the lead thinking that the electrodes will unwrap themselves. Per the surgeon, the patient had seen a ent a few weeks ago and received an implant in the left vocal cord to get the vagus nerve to more approximate normal location.

 
Manufacturer Narrative

Describe event or problem, corrected data: per notes dated (b)(6) 2015, patient was picking at the well healed site and managed to expose of the lead wires. A second surgery to remove the remaining portion of the device was performed as a result on (b)(6) 2015. This information was inadvertently left out of the previously submitted emdrs.

 
Event Description

Per notes dated (b)(6) 2015, patient was picking at the well healed site and managed to expose of the lead wires. A second surgery to remove the remaining portion of the device was performed as a result on (b)(6) 2015.

 
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Brand NamePULSE GEN MODEL 105
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 Key5001435
Report Number1644487-2015-05491
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/31/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/13/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/06/2017
Device MODEL Number105
Device LOT Number4295
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/05/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2015
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: 08/13/2015 Patient Sequence Number: 1
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