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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 11/01/2014
Event Type  Injury  
Event Description

Information was received from the surgeon on (b)(6) 2015. According to the patient the swelling, redness, and fluid accumulation started around (b)(6) 2014 after routine generator replacement the month before. The events are related to the presence of the device. Interventions were taken both for patient comfort and to preclude a serious injury. Additional interventions included wound irrigation and local steroid injections. The interventions were of minimal help. The surgeon believes the patient has developed a titanium allergy or hypersensitivity and that the only recourse is to totally remove the generator and lead. All cultures for infection have been negative.

 
Event Description

It was reported that the patient will be undergoing surgery to reposition the vns generator as it is extruding from the skin. There was no patient manipulation that led to the extrusion. The implanting surgeon did not use an absorbable suture for the placement of the generator and there were no known trauma or obvious cause for the extrusion of the device. The patient was seen by the neurologist¿s office in (b)(6) 2014 when patient had initially reported the extrusion but the neurologist office could not identify the cause of device extrusion. The patient underwent repositioning surgery on (b)(6) 2015. Following surgery, the patient experienced swelling, pain and redness in the chest. The patient was prescribed antibiotics prophylactically to prevent an infection. It was later reported that the patient had fluid coming from the generator site in the chest. The patient was admitted to the hospital on 02/20/20115 for the infection and was administered with antibiotics intravenously.

 
Manufacturer Narrative

 
Event Description

Additional information was received stating that the patient underwent generator replacement on (b)(6) 2015 for the previously reported infection. The explanted product was not returned to the manufacturer to date.

 
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 105
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 Key4565524
Report Number1644487-2015-04021
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/11/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/03/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2016
Device MODEL Number105
Device LOT Number3890
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/16/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/26/2014
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: 03/03/2015 Patient Sequence Number: 1
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