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

Model Number 102R

Device Problems Leak/Splash (1354); Device Inoperable (1663)

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

Event Date 01/01/2014

Event Type  malfunction  

Event Description

The patient¿s generator was replaced due to end of service and was returned for product analysis.The reported ¿end of service¿ allegation was duplicated in the product analysis laboratory.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.A battery life estimation resulted in 4.60 years remaining before the eri flag would be set.However, an incomplete programming history with multiple gaps (4-year gap, 3-year gap) indicates the estimation does not use all the data required to make an accurate estimation.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.

Manufacturer Narrative

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

• 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: 4317764
• MDR Text Key: 5251238
• Report Number: 1644487-2014-03254
• 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: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2007
• Device Model Number: 102R
• Device Lot Number: 012890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2014
• Event Location: Other
• Date Manufacturer Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2005
• 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: 62 YR