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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 10/13/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported the patient had an infection, which was first observed, on (b)(6) 2016. The patient's family had noted on (b)(6) 2016, prior to a normal scheduled follow-up visit on (b)(6) 2016, that they had observed some swelling and the generator implant location. The infection was confirmed on (b)(6) 2016 at the follow-up appointment and the patient had a chest ultrasound due to the infection on (b)(6) 2016. The patient underwent a full explant surgery on (b)(6) 2016. It was noted prior to surgery on (b)(6) 2016 that there was actually wound dehiscence which had occurred between (b)(6) 2016 and the surgery date. It was noted the reason for the infection is believed to be the fact that the generator was implanted in the axillary region and the patient is in a wheelchair and the sweat may be a contributing factor to the cause of the infection. Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution.

 
Event Description

The explanted generator and lead were received by the manufacturer for analysis. Product analysis is expected; however, it has not been completed to date.

 
Event Description

Product analysis (pa) for the returned generator and lead was completed. The allegation of infection was noted to be beyond the scope of the activities performed within the pa laboratory environment. However, potential contributing factors to this condition were considered/evaluated and none were found to exist. The generator diagnostics were as expected for the programmed parameters. The electrical test showed the generator performed according to functional specifications. There were no performance or any other types of adverse conditions found with the generator. Other than typical wear and explant related observations, no other anomalies were identified with the returned portion of the lead. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary could not be made on that portion.

 
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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 Key6055616
Report Number1644487-2016-02467
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/18/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/25/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/05/2017
Device MODEL Number105
Device LOT Number4264
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/22/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/10/2017
Was Device Evaluated By Manufacturer? Yes
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: 10/25/2016 Patient Sequence Number: 1
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