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

Model Number 104

Device Problem Failure to Advance (2524)

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

Event Date 10/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during generator replacement for end of service, the surgeon needed to reposition the generator pocket after placing the new generator in the device pocket.The surgeon was informed that using electrocautery while the generator was in the pocket was not advised.Device diagnostics then showed that the generator was at vbat >eos indicating that the generator may have been struck by electrocautery.The generator was not implanted and a new generator was placed with no issues.The generator was received for analysis.Analysis is underway, but has not been completed to date.

Event Description

Analysis of the generator was completed on 11/09/2015.An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator.Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification.Results of diagnostic testing indicated that the battery status indicated ok and the impedance value was normal.Electrical test results showed that the pulse generator performed according to functional specifications.Other than the pulse disabled condition there were no adverse functional, mechanical, or visual issues identified with the returned generator.

• Brand Name: PULSE GEN MODEL 104
• 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: 5199220
• MDR Text Key: 30603289
• Report Number: 1644487-2015-06324
• 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
• Report Date: 10/09/2015

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: Lay User/Patient
• Device Expiration Date: 04/14/2017
• Device Model Number: 104
• Device Lot Number: 4365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/09/2015
• Initial Date FDA Received: 11/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2015
• 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: 29 YR