MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK; GENERATOR

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Seizures (2063); Malaise (2359)

Event Type  Death  

Event Description

It was reported that the vns patient passed away.It was reported that the patient had been implanted with vns for many years and she died suddenly.It was reported that the emergency services were called by the patient¿s family and they were advised to initiate resuscitation maneuvers on the patient.It was reported that the paramedics used an automatic external defibrillator when they arrived.The automated external defibrillator did not advice to deliver any shocks.Further information was received stating that, on the date of death, the patient had indicated to her spouse that she felt unwell.Around 11:30 pm the patient suffered a severe seizure while in bed.Approximately one hour later, including the post-ictal period, the patient and the spouse fell asleep.Around 3:00 am the patient¿s spouse woke up and attempted to wake up the patient, but she did not react.The spouse requested medical aid and resuscitation maneuvers were started by family members.Upon arrival of the paramedics, an automated external defibrillator was used.The automated external defibrillator advised to continue with resuscitation and it did not advise to deliver shocks.It was reported that asystole was suspected.The resuscitation attempts were unsuccessful and the patient passed away.Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be probable sudep.Attempts to obtain further information have been unsuccessful to date.

• Brand Name: PULSE GEN MODEL UNK
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 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: 4952029
• MDR Text Key: 6033366
• Report Number: 1644487-2015-05365
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 07/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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