• 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 11/10/2014
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in high impedance (10,000 ohms). There was no trauma or manipulation that occurred that is believed to have caused or contributed to the high impedance. The device was programmed off and the patient was referred for surgery. Further follow-up revealed that the patient had undergone generator replacement on (b)(6) 2014. It was reported that device diagnostics on (b)(6) 2014 were within normal limits (3554 ohms). The patient was seen again on (b)(6) 2014 and device diagnostics were again within normal limits (3621 ohms). The physician assistant indicated that the generator was located in the axilla region and there was a possibility that the placement of the generator has caused the lead pin to become dislodged or the flexion of the patient's arm may have caused a fracture. X-rays were taken and it was reported that no lead discontinuity was identified. No known surgical interventions have been performed to date.

 
Event Description

It was reported that the patient had generator and lead replacement surgery on (b)(6) 2015. The explanted devices were discarded after surgery. Therefore, analysis is unable to be performed.

 
Manufacturer Narrative

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

 
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 770
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 Key4316945
Report Number1644487-2014-03246
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation PHYSICIAN ASSISTANT
Type of Report Initial,Followup
Report Date 11/10/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/10/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2002
Device MODEL Number300-20
Device LOT Number1596
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/06/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/28/2000
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-