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

Model Number 104

Device Problems High impedance (1291); Battery Problem (2885)

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

Event Date 06/16/2015

Event Type  malfunction  

Event Description

It was reported that during the patient's generator replacement, a new generator was opened and attached to the patient's leads.However, when diagnostics were run, it was reported that the new device showed both high impedance (>10,000 ohms) and end of service.A generator diagnostics was also performed with the test resistor in the generator, which also reportedly showed high impedance and eos.Thus, a new generator was taken from inventory and successfully implanted in the patient with normal impedance and battery status.The opened but unused generator has been returned to the manufacturer for analysis.However, analysis has not been completed to date.

Manufacturer Narrative

(b)(4).

Event Description

Analysis of the explanted generator was completed.An end-of-service warning message was verified and found to be associated with the output being disabled by the pulse generator.Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device implant/explant.Review of the ram/flash data downloaded from the generator showed that no diagnostics were performed on the pulse generator.Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, 3.096 volts as measured during completion of the final electrical test, shows an ifi=no condition.

• 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: 4899414
• MDR Text Key: 6831244
• Report Number: 1644487-2015-05109
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2016
• Device Model Number: 104
• Device Lot Number: 203240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2015
• 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: 60 YR