MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Code Available (3191)

Event Date 09/04/2008

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Analysis of a generator replaced prophylactically was completed on 06/24/2015.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications, with the exception of the test, 'backup cap neg to can'; 1129.093pf (limits 2700.00pf - 5400.00pf).However, two additional automated electrical evaluations showed that the pulse generator performed according to functional specifications.The most probable root cause for the backup capacitor test was identified to be an open capacitor, which manipulation of the feed-thru wires may have been a contributing factor.There were no additional performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

Age at time of event, corrected data: the initial report inadvertently reported the incorrect age.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• 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 Key: 4923798
• MDR Text Key: 22498239
• Report Number: 1644487-2015-05238
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2009
• Device Model Number: 103
• Device Lot Number: 200905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 12 YR