• 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. PULSE GEN MODEL 102R GENERATOR

  • 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. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/24/2017
Event Type  Injury  
Event Description

A call was received from the hospital requesting a product return number as the patient had undergone vns generator and lead explant due to wound dehiscence. The patient had been admitted to the er a few days prior to the explant surgery due to an unrelated issue, and the physician reported to the surgeon that he was able to see the generator through the patient's incision. It was confirmed there was no sign or suspicion of infection. Review of the dhr for the generator confirmed sterilization prior to distribution.

 
Event Description

Product analysis (pa) for the returned generator was completed. The reported ¿extrusion/generator¿ allegation is beyond the scope of the activities performed in the pa laboratory. During analysis, it was found that the device performed according to functional specifications and concluded that no abnormal performance, or any other types of adverse conditions, was found. It was later reported by the physician's office that they believe the patient had picked at the incision, which caused the extrusion. Pa for the returned lead was completed. The allegation of extrusion is not an actionable issue which will result in confirmation of an event and identification of a casual factor in the pa laboratory environment. Note that the lead assembly, including the electrode section, was not returned for analysis and thus a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102R
Type of DeviceGENERATOR
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 Key6341897
Report Number1644487-2017-03226
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/17/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/26/2017
Device MODEL Number102R
Device LOT Number203672
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/09/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/01/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/14/2016
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: 02/17/2017 Patient Sequence Number: 1
-
-