MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problems Electrical /Electronic Property Problem (1198); Failure to Interrogate (1332); Battery Problem (2885)

Patient Problem No Code Available (3191)

Event Date 02/15/2005

Event Type  malfunction  

Event Description

Analysis of a generator explanted due to being unable to be interrogated due to end of service was completed on (b)(6) 2015.The battery was determined to be depleted; however, the supply current tests did not meet functional specifications.The measurements demonstrated an increased current consumption for the device, potentially contributing to a premature end of life condition.The increased current consumption was isolated to a leaky capacitor (c6).With the capacitor substitution for c6, the pulse generator module performed according to functional specifications.The most probable root cause for the premature end of life condition was identified to be a leaky capacitor, c6.The cause for the c6 capacitors increase in leakage could not be determined.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5177913
• MDR Text Key: 30034357
• Report Number: 1644487-2015-06210
• 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
• Type of Report: Initial
• Report Date: 10/08/2015

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: 12/21/2006
• Device Model Number: 102
• Device Lot Number: 011989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/08/2015
• Initial Date FDA Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2005
• 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: 7 YR