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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/02/2016
Event Type  Injury  
Event Description

A report was received indicating that an abscess or blister had developed on the patient's chest incision. The reported indicated that the abscess was not leaking but appeared filled with pus and indicated that the wound appeared dehisced. It was unclear what caused the abscess/blister to form. The patient then sought treatment at an er when the abscess/ blister ruptured. The patient was prescribed antibiotics to treat the infection that was found when the abscess/ blister ruptured. The antibiotics reportedly cleared the infection. The device history record for both the generator and lead were reviewed. It was found that both devices had been sterilized prior to leaving the manufacturing facility. No other relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
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 Key6232562
Report Number1644487-2017-02973
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/09/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/09/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/10/2018
Device MODEL Number106
Device LOT Number203716
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/16/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/03/2016
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: 01/09/2017 Patient Sequence Number: 1
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