MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems Difficult to Interrogate (1331); Battery Problem (2885)

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

Event Date 10/01/2016

Event Type  malfunction  

Manufacturer Narrative

Suspect medical device udi: (b)(4).

Event Description

It was reported that the generator could not be interrogated.The believed cause of the failure to interrogate was battery depletion however the generator had only been implanted for approximately 14 months.Therefore it appeared that if the failure to interrogate was due to an end of service condition it would be premature.A review of manufacturing records indicated that the generator passed quality control inspection prior to distribution.Additionally, it was noted that the generator was laser routed during manufacture.The physician's programming data was received and reviewed.However there was not enough data to determine if the battery voltage of the device was depleting more quickly than expected.The patient underwent a generator replacement.The explanted product has not been received to date.No additional relevant information has been received to date.

Event Description

The explanted generator was received and is currently pending product analysis.

Event Description

Product analysis was completed on the explanted generator.Upon receipt it was noted that the generator would not interrogate.Therefore the internal data could not be downloaded and electrical testing could not be completed.The battery voltage was measured to be 0.073 v which confirmed an end of service condition.During analysis the generator was opened and the printed circuit board assembly (pcba) was assessed.It was noted that there were contaminates on the trimmed edge of the pcba.This resulted in a probable pathway that increased current consumption which contributed to the end of service condition.

• Brand Name: PULSE GEN MODEL 106
• 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: 6117591
• MDR Text Key: 60877980
• Report Number: 1644487-2016-02693
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/16/2017
• Device Model Number: 106
• Device Lot Number: 203410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/14/2016; 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2015
• 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: 15 YR