• 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 302-30
Device Problem High impedance
Event Date 01/23/2015
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in high impedance. The patient was referred for surgery. Clinic notes dated (b)(6) 2015 note that device diagnostics showed high impedance (dc dc code - 7). The generator was not programmed off after observing the high impedance. No known surgical interventions have been performed to date.

 
Event Description

The patient underwent generator replacement on (b)(6) 2015. Pre-operative device diagnostics resulted in high impedance (dc dc code - 7). The surgeon indicated that he was not aware that the lead needed to be replaced. A new generator was placed and the lead pin was confirmed to be fully inserted into the generator header. Device diagnostics again resulted in high impedance (9426 ohms). The surgeon refused to replace the patient's lead and indicated that the patient would have to come back for the lead replacement. The new generator was left programmed off. Clinic notes received indicates that lead replacement will occur after the generator incision site is completely healed. Further follow-up revealed that the explanting hospital discarded the explanted generator per protocol; therefore, no analysis can be performed. No known surgical interventions have been performed to date.

 
Event Description

It was reported that the patient underwent lead replacement surgery. The lead impedance with the new lead and existing generator was within normal limits. The explanted lead has not been received for analysis 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 that the explanted devices would not be returned for analysis because the explanting facility holds the products for seven years per the law and then discards.

 
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 Key4532420
Report Number1644487-2015-03926
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
Report Date 01/23/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/20/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2008
Device MODEL Number302-30
Device LOT Number1334
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/23/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/12/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-