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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 Migration or Expulsion of Device
Event Date 01/19/2014
Event Type  Injury  
Event Description

It was reported that there are no signs of infection and that reimplant is being planned.

 
Event Description

The generator was received for analysis on (b)(4) 2014. Analysis of the generator was completed on (b)(4) 2014. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

 
Event Description

It was reported that the patient experienced fever and redness over the generator. The patient was seen and admitted for iv antibiotics. It was reported that the generator had migrated across the chest wall to the anterior axillary fold and that the skin was inflamed. It was reported that the patient had undergone generator replacement in (b)(6) 2013. It was reported that the patient would likely undergo surgical exploration. Further follow-up revealed that swabs taken have come back negative to infection. It was reported that the generator was removed and the wound was washed out and debrided. It was reported that the lead was buried in the wound and sutured in place. A non-absorbable suture was reportedly utilized to secure the generator during initial implant surgery. It was reported that the micro analysis is underway, but that it is highly likely infection.

 
Event Description

An implant card was received indicating that the patient underwent generator implant on (b)(6) 2014.

 
Manufacturer Narrative

Review of device manufacturing records. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
Event Description

Additional information was received that no infection was found following first removal of device removed (b)(6) 2014.

 
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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 Key3632721
Report Number1644487-2014-00450
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/20/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/18/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2015
Device MODEL Number105
Device LOT Number202496
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/24/2014
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/04/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/09/2013
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: 02/18/2014 Patient Sequence Number: 1
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