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

Model Number 102

Device Problems Premature Discharge of Battery (1057); Leak/Splash (1354); Battery Problem (2885)

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

Event Date 05/13/2005

Event Type  malfunction  

Event Description

It was reported that the patient had generator replacement on (b)(6) 2014 due to neos=yes according to the referring nurse practitioner.Analysis of the generator was completed on (b)(6) 2015.The elective replacement indicator flag was set and an open can measurement of the battery voltage confirmed that the eri flag had been properly set; the battery was operating at low voltage (depleted level).With the exception of the eri parameter (eri flag was set to ¿yes¿ due to a low battery condition), the device performed according to functional specifications.It was identified that there was increased current consumption for the device which potentially contributed to a premature end of the battery life.Analysis on the test bench identified and confirmed that c6 had excessive leakage current.With the capacitor substitution for c6, the pulse generator module performed according to the functional specifications.The most probable root cause for the premature end of service and low battery condition was identified to be a leaky capacitor, c6.

Manufacturer Narrative

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

• Brand Name: PULSE GEN MODEL 102
• 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: 4480816
• MDR Text Key: 20788729
• Report Number: 1644487-2015-03740
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2015
• 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: 102
• Device Lot Number: 012830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2005
• 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: 44 YR