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

Model Number 103

Device Problems High impedance (1291); Difficult to Remove (1528)

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

Event Date 01/27/2015

Event Type  malfunction  

Event Description

It was reported that during generator replacement for end of service, device diagnostics resulted in high impedance with the new generator connected to the existing lead (mfr.Report # 1644487-2015-03930).When the high impedance was observed the surgeon attempted to remove the lead pins from the generator header; however, the surgeon experienced difficulties removing the lead from the generator header.The surgeon then explanted the lead and did not implant the generator.The explanted generator was received for analysis with the lead pin inserted into the generator header.Analysis is underway, but has not been completed to date.

Manufacturer Narrative

Manufacturer Narrative

(b)(4).Corrected data: the previously submitted mdr inadvertently did not provide the udi number of the suspect device.

Event Description

Analysis of the returned generator was completed on 03/03/2015 and it found no obstructions in the header lead cavity or the connector blocks.A bench lead was fully inserted into the generator header and removed with no difficulties.The setscrew was not returned.X-rays of the generator in as-received conditions shows that the negative connector block contains no setscrew.X-rays of the generator after manufacture shows that the setscrew was installed in the negative connector block.The pulse generator battery was found to be in an ifi=no condition.No adverse conditions were found with the pulse generator.Analysis of the lead was reported in manufacturer report # 1644487-2015-03930.

• Brand Name: PULSE GEN MODEL 103
• 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: 4551293
• MDR Text Key: 5524225
• Report Number: 1644487-2015-03985
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2015

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: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: 103
• Device Lot Number: 4084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 02/26/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/17/2015; 04/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2014
• 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: 13 YR