• 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 BIPOL LEAD MODEL 300

  • 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 BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 01/30/2015
Event Type  Injury  
Event Description

It was reported that the vns patient¿s lead was protruding through the patient¿s skin. Patient manipulation is not believed to have caused or contributed to the protrusion. Operative notes were received indicating that the patient¿s lead was well incorporated into the patient¿s skin at the previous generator replacement surgery on (b)(6) 2012. The patient underwent generator and lead replacement surgery on (b)(6) 2015. The notes indicate that at least two loops of the lead were protruding from a defect in the skin of the left neck. There was no pus, erythema, fever or chills. The explanted devices have been returned to the manufacturer where analysis is currently underway.

 
Event Description

Product analysis for the lead completed on 3/12/2015. Scanning electron microscopy of the positive and negative lead coils show that pitting or electro-etching conditions have occurred on the coil surfaces. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant (generator was still programmed to deliver an output, attempting to deliver therapy through an open electrical load - cut leads). Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

 
Event Description

The analysis was completed on the patient's explanted generator. The explanted lead analysis is pending completion. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIPOL LEAD MODEL 300
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 Key4542004
Report Number1644487-2015-03964
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 01/30/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2001
Device MODEL Number300-20
Device LOT Number27396C
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/12/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/12/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/26/1999
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: 02/24/2015 Patient Sequence Number: 1
-
-