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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 07/21/2014
Event Type  Injury  
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.

 
Event Description

It was reported that the patient was seen in the emergency room the past friday night. The patient was started on antibiotics and did not have any fever. The patient was scheduled to see the surgeon. The patient had recently undergone generator replacement. The patient was seen by the surgeon who drained "milky fluid" from the wound at the chest pocket. The area was flushed and cultures were taken. The surgeon administered iv antibiotics. The surgeon believes an infection is present and was considering explant. It was later reported that the patient was experiencing wound dehiscence. The patient's family feels the device needs to be removed. The patient was admitted to the hospital and underwent generator explant. It was reported that the lead was left in place. Attempts to obtain additional information have been unsuccessful to date.

 
Event Description

The physician reported that the cultures were positive for staphylococcus aureus. It was reported that the generator and a portion of the lead were explanted. The physician reported that the infection was a result of implant surgery and the presence of the device. There wa no patient manipulation or trauma that is believed to have caused or contributed to the infection. The device protrusion was secondary to the wound infection and wound dehiscence. The patient is now stable and did not experience systemic symptoms and the local infection has resolved.

 
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Brand NamePULSE GEN MODEL 103
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 Key4018076
Report Number1644487-2014-02043
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/21/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/18/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2015
Device MODEL Number103
Device LOT Number3836
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/04/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/08/2014
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: 08/18/2014 Patient Sequence Number: 1
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