MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem High impedance (1291)

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

Event Date 11/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2016, patient underwent generator replacement.When the new generator was connected to existing lead, high impedance was observed.The surgeon attempted to reinsert the pin, but the high impedance did not resolve.The surgeon backed the set screw all the way out and was unable to put it back in.The surgeon then used a new generator.Diagnostics with the new generator still observed high impedance.As a result, the lead was replaced.Further clarification was received from the operating room specialist.The generator was replaced and the lead pin was inserted into the lead pin and the set screw was tightened.During system diagnostics, high impedance was observed.The operating room specialist instructed the surgeon to remove the lead pin and reinsert it.The surgeon unscrewed the setscrew too far and the septum plug came out while trying to remove the lead pin to re-insert it.The septum plug came out during the unscrewing process.The surgeon wanted to implant a new generator as a result.The high impedance persisted with the new generator and so the lead was revised.After lead and generator revision, the high impedance resolved.Per the hospital policy, the products may not be returned.The suspect generator has not been received to date.The high impedance issue is reported in mfr.Report# 1644487-2007-01886.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6130288
• MDR Text Key: 61293185
• Report Number: 1644487-2016-02739
• 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
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2016
• Device Model Number: 106
• Device Lot Number: 4809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2016
• 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: 27 YR