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

Model Number 106

Device Problem Failure to Select Signal (1582)

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

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported during device implantation that the device could not detect heart rate.A pre-operative assessment to evaluate whether the patient was a good candidate for tachycardia detection was not performed.All sensitivity settings were used to try to verify the heartbeat, diagnostics were normal, and the battery of the programming wand being used was confirmed to be functioning.The wand was reportedly held still during verification and was reportedly communicating well with the generator.Additionally, the patient's generator was reported to be implanted close to the heart in the left chest.Throughout the surgery the patient's heart-rate was 60-62 bpm.The surgeon did not want to try moving the generator to a different location to test if this solved the issue.A review of the device history records confirmed that the suspect device passed all quality inspections prior to release internal data was reviewed.It was determined that the device was turned on prior to heartbeat verification and could have been stimulating during verification, which could cause have caused interference.Only one interrogation was taken after heartbeat detection was turned on.It captured a foreground heart-rate of 60, which is the default value shown during interrogations when the device is not sensing a heart-rate.Therefore, it was likely that a valid heart rate had not yet been detected.No further relevant information has been received to date.No known surgical intervention has occurred to date.

• 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: 6179378
• MDR Text Key: 62848654
• Report Number: 1644487-2016-02876
• 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: 11/30/2016

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: 04/26/2018
• Device Model Number: 106
• Device Lot Number: 203818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2016
• 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: 36 YR