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MAUDE Adverse Event Report

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CYBERONICS, INC. PULSE GEN MODEL 102 LYJ   Back to Search Results
Model Number 102
Event Date 01/17/2006
Event Type  Injury   Patient Outcome  Hospitalization; Required Intervention
Manufacturer Narrative

Manufacturing records for the pulse generator were reviewed, for sterilization. Manufacturing records for the pulse generator confirmed sterilization of the device prior to distribution. Vns therapy system labeling lists infection as a potential adverse event possibly associated with surgery.

 
Event Description

Reporter indicated two days post initial implant; infection was noted at the generator site. The patient was prescribed antibiotics. Approximately eight weeks later, signs of infection returned at the generator pocket. Again, antibiotics were prescribed. After the infection cleared, revision surgery was performed to relocate the generator deeper in the chest. Six weeks after surgery, the patient had picked the led out of her body and was holding it in her hands. The physician believes the extrusion event was caused by patient interaction, picking at the lead site. The patient had the generator and lead explanted and is reportedly doing well. Available information suggests that the initial infection was related to the surgical procedure.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceLYJ
Manufacturer (Section D)
CYBERONICS, INC.
houston TX *
Manufacturer Contact
donnie welty, rn, bsn
100 cyberonics blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key748736
MDR Report Key760813
Event Key725338
Report Number1644487-2006-00332
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/02/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/14/2006
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date03/31/2007
Device MODEL Number102
Device LOT Number012565
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/02/2006
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

 
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