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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 08/11/2014
Event Type  Injury  
Event Description

Initially, it was reported that the patient underwent generator replacement for an unknown reason. Further follow-up revealed that the generator was replaced due to left anterior chest wound dehiscence with purulent drainage. The patient underwent a "washout" of the left anterior chest wall with generator replacement. No patient manipulation or trauma occurred that is believed to have caused or contributed to the wound dehiscence. There were no medication changes that could have caused or contributed to the wound dehiscence. The explanted generator was received for analysis. Analysis was completed on 09/22/2014. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Manufacturer Narrative

Method: device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.

 
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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 Key4281354
Report Number1644487-2014-03163
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/31/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/26/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2015
Device MODEL Number103
Device LOT Number202534
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/21/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/31/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/12/2013
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: 11/26/2014 Patient Sequence Number: 1
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