MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 101; GENERATOR

Model Number 101

Device Problems Electrical /Electronic Property Problem (1198); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 10/01/2001

Event Type  malfunction  

Event Description

During analysis of the returned generator that was explanted due to near end of service, it was found that the supply current pulsing was out of specification on the current automated post burn test.Analysis indicated that during manufacture of the generator, the r35 resistor (a selectable value resistor) could have been more optimally chosen.A lower value resistor would have more suitably centered the currents within their limits.After r35 was optimally reselected, the device performed according to functional specifications.The out-of-specification supply current pulsing could potentially be a contributing factor to the end of service condition; however, results of the battery longevity calculation indicated that the end of service condition was an expected event.

• Brand Name: PULSE GEN MODEL 101
• 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: 4860395
• MDR Text Key: 19031647
• Report Number: 1644487-2015-04967
• 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: 06/02/2015

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: 03/31/2003
• Device Model Number: 101
• Device Lot Number: 4309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/02/2015
• Initial Date FDA Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2001
• 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: 21 YR