MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problems Break (1069); High impedance (1291)

Patient Problem Neck Pain (2433)

Event Date 04/01/2015

Event Type  Injury  

Event Description

It was originally reported that the patient was experiencing pain in the neck at the site of the electrodes and in the chest at the site of the generator.The generator was programmed off on (b)(6) 2015.It was reported that the patient underwent surgery to replace the generator on (b)(6) 2015.Pre-operation diagnostic results were checked on the original generator and lead and the results were within normal range.Once the new generator was attached to the original lead, diagnostics were checked and impedance was above normal range.The pin of the original lead was reinserted into the generator and during this process the lead broke.The broken lead is reported under mfr.Report # 1644487-2015-04830.It was noted by the surgeons that the original placement of the lead was not well done and seemed "tight" (no slack) before the lead finally broke.Due to the lead break, a full revision was performed and diagnostics were run and the results were within acceptable ranges.The generator and lead have not been received to date.

Manufacturer Narrative

Conclusions; corrected data: the code was incorrectly reported on the initial mfr.Report.

• Brand Name: PULSE GEN MODEL 104
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4816140
• MDR Text Key: 5925965
• Report Number: 1644487-2015-04828
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/05/2014
• Device Model Number: 104
• Device Lot Number: 202321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/22/2015
• Initial Date FDA Received: 06/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2012
• 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 Outcome(s): Hospitalization
• Patient Age: 17 YR