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

Model Number 105

Device Problem Battery Problem (2885)

Patient Problem No Code Available (3191)

Event Date 04/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on 04/28/2016 that during a replacement surgery on (b)(6) 2016 (replacement housed in file (b)(4)).The or specialist called to return a generator that was opened but not used during the replacement surgery.It was stated that the generator was opened in the or, interrogated, programmed, put in the patient, re-interrogated and was the battery was dead.The surgeon was using cautery.The generator was received for analysis on 05/10/2016.Product analysis is underway but has not been completed to date.

Event Description

Product analysis for the generator was completed and approved on 05/26/2016.Review of the data downloaded from the pulse generator indicated that the pulse disabled byte was set to a value that represents a vbat's eos threshold condition.However, burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant/explant, which may have been a contributing factor.A reset of the pulsedisabled bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

• 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: 5673693
• MDR Text Key: 46860053
• Report Number: 1644487-2016-01102
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/12/2017
• Device Model Number: 105
• Device Lot Number: 4275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2015
• 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: 61 YR