MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Disconnection (1171); Premature End-of-Life Indicator (1480); Device Inoperable (1663)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 11/01/2016

Event Type  malfunction  

Event Description

It was reported that after a surgery that was taking place for lead repositioning purposes, the generator was found near end of service.The generator was not near end of service before the surgery.Electrocautery was reportedly used in the lead repositioning surgery.Due to the generator being found at near end of service after the lead repositioning surgery, the generator was explanted during that surgery.A lead discontinuity was identified during this surgery.The lead discontinuity has been reported under mfr.Report #1644487-2016-02708.System diagnostics both pre-operatively and post-operatively were within normal limits.The explanted generator has not been received to date.

Event Description

The explanted generator was received for product analysis.Analysis has not been completed to date.

Manufacturer Narrative

(b)(4).

Event Description

The generator was returned and had product analysis completed.The generator data was reviewed and showed that the pulse disabled byte had been activated.Additionally, the generator had visible burn marks on its case.The pulse disabled byte was reset and the generator was able to adequately provide the intended therapy when it was monitored in a simulated body environment for a period of over 24 hours.The generator diagnostics were as expected for the programmed parameters and a comprehensive electrical evaluation showed that the generator performed according to functional specifications.The measured battery voltage and the measured charge consumed did not indicate an end of service condition.

• Brand Name: PULSE GEN MODEL 103
• 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: 6120646
• MDR Text Key: 60935132
• Report Number: 1644487-2016-02707
• 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: 01/26/2017

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: 01/31/2015
• Device Model Number: 103
• Device Lot Number: 3686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/05/2017; 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2013
• 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: 16 YR