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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 04/05/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient's devices were explanted less than a month from initial implant on (b)(6) 2016 due to infection. Patient is on a 6-8 week antibiotic therapy to clear infection. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

 
Event Description

Additional information was received that the patient is experiencing hoarseness and coughing which began shortly after the explant surgery. It was initially thought to be bronchitis, but they now believe it to be related to the explant surgery. The patient has been referred to see an ent to assess the adverse events. Patient's hoarseness and coughing had not resolved and patient was provided medication for bronchitis and reflux. Patient saw a pulmonologist on (b)(6) 2016 who stated that the patient developed acute bronchitis. The cause of the bronchitis is unknown. Patient had a pre-existing diagnosis of asthma prior to implant surgery.

 
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Brand NamePULSE GEN MODEL 103
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 Key5659628
Report Number1644487-2016-01042
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/03/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/17/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/08/2016
Device MODEL Number103
Device LOT Number203722
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/07/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/09/2016
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: 05/17/2016 Patient Sequence Number: 1
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