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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 07/11/2014
Event Type  Injury  
Event Description

It was reported that the patient was scheduled for surgical exploration of the generator incision site. It was reported that the patient's wound was not healing poorly. The operative notes dated (b)(6) 2014 note that the patient is an avid hunter and shoots his gun from his left shoulder. It was noted that the generator is implanted on the right side of the patient's chest. It was noted that the patient was admitted to the hospital on (b)(6) 2014 with the medial 1-2 cm of his right chest incision broken down and a small piece of the lead and generator exposed. Further follow-up revealed that cultures were negative for infection. The patient was taken back to the hospital on (b)(6) 2014 because the incision opened up again. The patient underwent generator explant. It was reported that the lead was left in place. The patient requested explant of the device. The surgeon plans to wait a couple of months with the generator removed so the incision can heal and then reimplant another generator. There was no known cause for the impaired incision healing. It was reported that the patient has had good healing prior to vns implant. The explanted generator was discarded; therefore, will not be returned for analysis.

 
Manufacturer Narrative

 
Manufacturer Narrative

Conclusions, initial report inadvertently omitted. Conclusion code for device discarded.

 
Event Description

The patient has decided not to re-implant the vns device for fear of infection recurring.

 
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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 Key4051959
Report Number1644487-2014-02153
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/04/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2015
Device MODEL Number105
Device LOT Number3813
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/01/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/06/2013
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: 09/02/2014 Patient Sequence Number: 1
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