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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 04/05/2012
Event Type  Malfunction  
Event Description

It was reported that the patient's vns was now indicating high impedance with dcdc=7 during a system diagnostic test. The patient has not had any adverse events however the physician indicated that she believes the generator has been migrating towards the patient's armpit. The physician indicated that this migration could have contributed to the high impedance. X-rays were taken that reportedly did not indicate any issues however they will not be sent to the manufacturer for review. No trauma or manipulation is believed to have occurred. Last known diagnostics were taken on (b)(6) 2010. Attempts for additional information have been unsuccessful to date.

 
Event Description

Surgery to replace the patient's lead and generator has occurred. Diagnostic results following lead and generator replacement were normal following replacement. It was noted that a non-absorbable suture had been previously used to secure the generator. Attempts for the return of the explanted lead and generator were unsuccessful as the implant hospital indicated they believe the explants had been discarded after surgery.

 
Manufacturer Narrative

Device failure is suspected.

 
Manufacturer Narrative

Type of report, corrected data: initial report inadvertently did not indicate "30-day. ".

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2560371
Report Number1644487-2012-01143
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/05/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/04/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2010
Device MODEL Number302-20
Device LOT Number200419
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/04/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/12/2007
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: 05/04/2012 Patient Sequence Number: 1
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