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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 08/12/2014
Event Type  Malfunction  
Event Description

Patient and product information was obtained. Patient trauma is not believed to have occurred but the physician noted that the patient was on a trampoline two days following replacement surgery.

 
Manufacturer Narrative

Brand name; corrected data: additional information revealed the product information for the generator.

 
Event Description

It was reported that three days following generator replacement, the patient was seen and x-rays identified that the lead pin was not fully inserted into the generator header. It was later reported that device diagnostics during generator replacement surgery when the new generator was attached to the existing lead were within normal limits (~3000 ohms). The patient was closed and surgery was ended. Postop diagnostics were performed which again were within normal limits. It was reported that the patient's parents called the nurse the following friday and reported that the suspected something was not right with the vns. X-rays were then arranged. It was reported that x-rays were not available for manufacturer to review. The patient was sent for surgery the same day and the generator and lead connection was rectified. It was reported that the surgeon indicated that he did not hear two clicks when tightening the set screw into the new generator at the generator replacement surgery. The surgeon felt that he had been tightening the set screw for a while and did not want to over do it.

 
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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 Key4089829
Report Number1644487-2014-02343
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/15/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2016
Device MODEL Number103
Device LOT Number202820
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/24/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/12/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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