MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Protective Measures Problem (3015)

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

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Product analysis was completed for a generator replaced for prophylactic reasons.The generator did not meet the specifications for both backup capacitor-to-can measurements due to the positive backup capacitor's open condition, causing an additional measurement to be out of specification.It is suspected that the positive backup capacitor was not electrically attached to the feedthru wire, causing the open condition.After the generator can was opened, internal visual assessment on the positive feed-thru assembly showed separation of the silver polyimide to the feed-thru wire connections.After the positive backup capacitor was bridged, the device performed according to functional specifications.No anomalies were observed with the internal circuitry of the generator.With the exception of the noted conditions, there was no adverse finding that would inhibit this product from performing as intended.No additional relevant information has been received to date.

Manufacturer Narrative

Date of event; corrected data; initial mdr inadvertently listed wrong date of event.

• Brand Name: PULSE GEN MODEL 102
• 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: 7392591
• MDR Text Key: 104272350
• Report Number: 1644487-2018-00510
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

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: 08/31/2013
• Device Model Number: 102
• Device Lot Number: 201866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 05/21/2018
• Supplement Dates FDA Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2011
• 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: 57 YR