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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/28/2016
Event Type  Injury  
Manufacturer Narrative

Device evaluation is not necessary because the reported events of dehiscence, infection, and allergic reaction have been determined as not related to vns therapy.

 
Event Description

It was reported that the patient experienced an allergic reaction to tacaderm and dermabond following the previous vns generator replacement. Due to this the patient's wound became infected and the patient required several weeks of bed rest for the wound to heal. Clinic notes were later received that the patient had wound breakdown which required wet to dry packing for a couple of months. It was also reported that the patient may have opened her wound during a pseudoseizure after the replacement which contributed to the post-op complications. A review of the internal manufacturing records showed that the generator was sterilized prior to distribution. It was also reported that the patient's generator had migrated after the implant surgery which is reported in mfg report # 1644487-2017-04286. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6789883
Report Number1644487-2017-04284
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/11/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/11/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/10/2017
Device MODEL Number102
Device LOT Number4315
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/17/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/21/2015
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: 08/11/2017 Patient Sequence Number: 1
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