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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 09/26/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that a patient's generator was explanted on (b)(6) 2016 due to an infection. The device history record of the generator was reviewed, and the device was sterilized prior to release. The generator was received on 10/04/2016. Analysis was approved on (b)(6)2016. The device performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. No further relevant information has been received to date.

 
Event Description

The physician did not know when the infection began. The patient slowly developed wound dehiscence after implant in (b)(6) 2015 that led to an infection and visualization of the generator. This led to the explant. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102R
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 Key6051125
Report Number1644487-2016-02449
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/29/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/24/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/23/2017
Device MODEL Number102R
Device LOT Number4593
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/04/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/28/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/28/2015
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: 10/24/2016 Patient Sequence Number: 1
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