MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102R; GENERATOR

Model Number 102R

Device Problems Leak/Splash (1354); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2006

Event Type  malfunction  

Event Description

Analysis of a generator explanted for end of service was completed on (b)(4) 2014.The supply current tests did not meet functional specifications.These measurements demonstrate 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 (c4).A battery life estimation resulted in 0.48 years remaining before the eri flag would be set.However, an incomplete programming history indicates the estimation does not use all the data required to make an accurate estimation.With the capacitor substitution for c4, 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, c4.The cause for the c4 capacitors increase in leakage could not be determined.

Manufacturer Narrative

The generator was found to have a leaky capacitor, potentially contributing to a premature end of service condition.

• Brand Name: PULSE GEN MODEL 102R
• 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: 3800932
• MDR Text Key: 4383573
• Report Number: 1644487-2014-01227
• 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: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2008
• Device Model Number: 102R
• Device Lot Number: 015709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2014
• Event Location: Other
• Date Manufacturer Received: 04/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2006
• 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: 46 YR