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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 06/19/2013
Event Type  Injury  
Event Description

On (b)(6) 2013, additonal product information was received.

 
Event Description

On (b)(6) 2013, it was reported that this vns patient underwent full explant due to infection. The physician believed that the patient twiddled which may have been the cause of the infection. Cultures were taken and came out negative for (b)(6), but the physicians still believe there is an infection. The patient was on antibiotics. Follow-up showed that the explant surgery took place on (b)(6) 2013. The patient¿s father noticed on (b)(6) 2013 that the chest incision site had split open. The patient went to the emergency room and then underwent explant. The patient was scheduled for a later lead revision due to high impedance. The high impedance event is captured in mfr report #1644487-2013-01959.

 
Event Description

On (b)(4) 2013, it was reported that the explanted products were discarded.

 
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Brand NamePULSE GEN MODEL 102R
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 Key3202684
Report Number1644487-2013-01998
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/27/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2014
Device MODEL Number102R
Device LOT Number202207
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/03/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/31/2012
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: 07/02/2013 Patient Sequence Number: 1
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