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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Event Date 01/27/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient developed staph infection at the generator site that required system explant. The physician indicated that during explant she found signs of infection at the generator site and along the lead. It was reported that the tissue was "like concrete" and required her to cut the lead into pieces to remove it. The surgeon indicated that all of the infection was removed and indicated that prior to, during and after surgery they used several precautions to avoid infection. The surgeon indicated that initially after implant the patient was healing fine; however, over time the redness started and the infection became much worse. No patient manipulation or trauma is suspected to have caused the infection. The surgeon indicated that the patient was very cautious about the incision. The surgeon plans to reimplant the patient when the infection resolves. A review of device history records showed that both the lead and generator were sterilized prior to distribution. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.

 
Event Description

Analysis of the generator was completed on 03/11/2016. There were no performance or any other type of adverse condition found with the pulse generator. Analysis of the lead was completed on 03/21/2016. Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

 
Event Description

Clinic notes dated (b)(6) 2016 note that the patient's incisions are all healed. It was noted that the patient would like to proceed with re-implant. The generator will be placed on the right chest given the adhesions on the left chest wall. There is no pain over the patient's scars.

 
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Brand NamePULSE GEN MODEL 106
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 Key5451173
Report Number1644487-2016-00381
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/27/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/23/2017
Device MODEL Number106
Device LOT Number203410
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/18/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/16/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/09/2015
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: 02/22/2016 Patient Sequence Number: 1
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