MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem High impedance (1291)

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

Event Date 11/21/2017

Event Type  malfunction  

Event Description

A company representative reported that during a replacement surgery for battery depletion, the patient¿s replacement device was programmed on and then high impedance was observed.It was reported that after several more tries high impedance was still observed.The company representative turned off the tablet and restarted it, programmed the generator back to 0.0ma and then measured impedance again and the results were normal.The company representative stated that the attempts were systems diagnostics and were not interrogations.The device was programmed to 3.5 ma when the high impedance message was provided.The lead was not replaced.Additional relevant information has not been received to-date.No known surgery has occurred to-date.

Event Description

Follow-up from the company representative provided that the high impedance had been resolved during surgery as the result of pin re-insertion.

Manufacturer Narrative

Unique identifier (udi) #, corrected data: the udi for the suspect device was inadvertently not provided on follow-up report #1.

• Brand Name: PULSE GEN MODEL 105
• 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: 7124557
• MDR Text Key: 95189353
• Report Number: 1644487-2017-05021
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2019
• Device Model Number: 105
• Device Lot Number: 5185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2007
• 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