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

Model Number 102R

Device Problems Leak/Splash (1354); Low Battery (2584); Improper Device Output (2953)

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

Event Date 06/19/2015

Event Type  malfunction  

Event Description

The patient underwent a generator replacement surgery on (b)(6) 2015 due to low battery, near end of service=yes.The explanted generator was received by the manufacturer for analysis.Analysis was completed.The reported end of service allegation, was duplicated in the analysis laboratory.However, 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 (c6).The pulse generator performed according to functional specifications except for the tests that were due to the low battery condition.With the capacitor substitution for c6, the pulse generator module performed according to functional specifications.The cause for the c6 capacitors increase in leakage could not be determined.

• Brand Name: PULSE GEN MODEL 102R
• 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: 5225831
• MDR Text Key: 31578160
• Report Number: 1644487-2015-06417
• 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: 10/21/2015

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: 09/30/2012
• Device Model Number: 102R
• Device Lot Number: 2824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/21/2015
• Initial Date FDA Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2010
• 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: 42 YR