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

Model Number 102

Device Problems Premature Discharge of Battery (1057); Electrical /Electronic Property Problem (1198); Battery Problem (2885)

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

Event Date 02/16/2006

Event Type  malfunction  

Event Description

Analysis of a generator explanted due to being depleted was completed on (b)(6) 2016.The battery was determined to be depleted; however, analysis found that the supply currents and supply wait current measurements did not meet the specification requirements.Analysis on the test bench identified and confirmed c6 as the root cause for the increased current drains.After the c6 component was cut out of the circuit and bridged with a known good bench c6 component, the generator module performed according to the functional specifications.The c6 leakage current demonstrated an increased current consumption for the device and potentially contributing to a premature end of the battery life.The reason for the c6 capacitor's increase in leakage current could not be determined.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 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: 5418871
• MDR Text Key: 38457394
• Report Number: 1644487-2016-00264
• 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: 01/19/2016

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: 06/30/2007
• Device Model Number: 102
• Device Lot Number: 013755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/19/2016
• Initial Date FDA Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2006
• 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: 17 YR