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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 12/19/2014
Event Type  Injury  
Event Description

It was reported that the patient developed an infection at the generator site and would undergo generator explant. It was reported that the surgeon would clean the generator pocket and then making a new generator pocket and implanting another generator. It was later reported that the patient presented to surgery with a badly infected generator pocket with an open wound and the generator missing. It was reported that the lead was sticking out of the pocket with the lead pins torn off. It was presumed that the lead pins were still connected to the missing generator. The surgeon decided to explant the lead and let the mrsa infection heal before re-implanting in 2-4 weeks. It was reported that the patient did not know what happened to the generator. The surgeon indicated that the chest wound broke down and extruded. The patient initially had a seroma, but that the generator eventually extruded through the skin. No additional relevant information has been received to date.

 
Event Description

Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. On 03/11/2015 it was reported that the physician lacerated the carotid artery of the patient during the re-implant surgery. A vascular surgeon was called in to assist. After 7 hours, the patient appeared to be stable and was sent to the icu to stay the evening.

 
Manufacturer Narrative

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

 
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Brand NamePULSE GEN MODEL 103
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 Key4532501
Report Number1644487-2015-03928
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/29/2016
Device MODEL Number103
Device LOT Number3884
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/22/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/05/2014
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: 02/20/2015 Patient Sequence Number: 1
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