• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 01/21/2015
Event Type  Malfunction  
Event Description

It was reported that during generator replacement surgery, device diagnostics resulted in high impedance (dcdc=7). It was reported that device diagnostics were unable to be performed prior to generator replacement due to the previous generator being at end of service. A pin reinsertion was performed which did not resolve the high impedance. The surgeon left the lead implanted. Lead revision surgery will be planned at a later date. No known surgical interventions have been performed to date.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

It was reported in clinic notes that the patient had lead revision surgery. No further relevant information has been received to date.

 
Manufacturer Narrative

Explant date, corrected data: follow-up report #1 inadvertently listed the incorrect explant date of the suspect device.

 
Event Description

The explanted lead was discarded. Therefore, no analysis could be performed.

 
Event Description

Clarification was received through operative notes that the patient's lead was not explanted in (b)(6) 2015. Exploratory surgery was performed, and the high impedance resolved after the lead pin was reinserted into the generator. The high impedance then was present again in (b)(6) 2017. Therefore, the high impedance resolved only temporarily. The report of high impedance after (b)(6) 2017 was initially reported in mfr. Report #1644487-2017-03204 as it was believed to be on a different lead. The patient had full revision surgery, but the products were discarded by the explanting facility. No further relevant information has been received to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 302
Type of DeviceLEAD
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 Key4600592
Report Number1644487-2015-04145
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/20/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/13/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2011
Device MODEL Number302-20
Device LOT Number2224
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/17/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/29/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-