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

Model Number 102

Device Problems Leak/Splash (1354); Low Battery (2584)

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

Event Date 08/12/2009

Event Type  malfunction  

Event Description

It was reported that the patient had prophylactic generator replacement on (b)(6) 2014.Analysis of the generator was completed on 09/09/2015.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.A review of device history records showed that the generator passed all electrical tests and performed to functional specifications.

• 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: 5123637
• MDR Text Key: 27650514
• Report Number: 1644487-2015-05990
• 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: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2011
• Device Model Number: 102
• Device Lot Number: 2429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2009
• 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: 35 YR