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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 304

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CYBERONICS INC LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem Weight Changes (2607)
Event Date 04/15/2014
Event Type  Injury  
Event Description
It was reported that the vns patient was scheduled for surgery to replace his generator due to end of service on (b)(6) 2014.During the procedure, it was determined that the patient¿s device was not at end of service so the generator was not replaced at the time.The surgeon noted during the procedure that the patient¿s lead was extruding from his neck.Intervention was required to prevent any adverse events as the lead was exposed.The surgeon buried the lead medially and secured it with a suture.Further follow-up revealed that the patient may have been manipulating the lead but the patient denied any manipulation or trauma had occurred.The patient did not have any physiological changes that may have caused or contributed to the reported event.It was noted that the patient had lost 10 kg since his last revision surgery in 2012.
 
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Brand Name
LEAD MODEL 304
Type of Device
LEAD
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 Key3803231
MDR Text Key4526220
Report Number1644487-2014-01234
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date10/09/2015
Device Model Number304-20
Device Lot Number3131
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 04/15/2014
Initial Date FDA Received05/09/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/11/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age36 YR
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