MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 101; GENERATOR

Model Number 101

Device Problems Device Operates Differently Than Expected (2913); Battery Problem: High Impedance (2947)

Patient Problem Death (1802)

Event Date 03/03/2013

Event Type  Death  

Event Description

It was reported that the patient passed away on (b)(6) 2013.The death was identified through an obituary search as the patient's device was suspected to be at end-of-service based on battery life expectancy.The patient's device was known to have been programmed off in 2011.Programming history was available up to 2005, and high impedance was present in the patient's device (reported in mfr.Report #1644487-2008-02590).Attempts to the treating physician were unsuccessful, so it is unknown if the patient's device was programmed back on prior to the patient's death.It was reported by the funeral home attendant that the death was thought to have been due to a fall that lead to complications, ultimately causing death.However, the official cause of death was not available.The patient's device was not explanted.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 101
• 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: 6176795
• MDR Text Key: 62442779
• Report Number: 1644487-2016-02869
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2003
• Device Model Number: 101
• Device Lot Number: 5985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2002
• 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 Outcome(s): Death
• Patient Age: 47 YR