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

Model Number 102

Device Problems Low Battery (2584); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 05/01/2017

Event Type  malfunction  

Event Description

The patient reported having an increased level of seizures.Additional relevant information has not been received to date.

Event Description

Patient underwent generator replacement.The explanted generator has not been received to date.

Manufacturer Narrative

(b)(4).

Event Description

The generator was received and analysis was performed.The reported ¿end of service¿ was confirmed in the lab.An open can measurement of the battery voltage confirmed that the battery was depleted.The ¿depleted battery¿ condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation.Analysis of the generator in the lab concluded that no abnormal performance or any other type of adverse condition was found.

• 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: 6595266
• MDR Text Key: 76086992
• Report Number: 1644487-2017-03886
• 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,consum
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2017

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: 01/31/2006
• Device Model Number: 102
• Device Lot Number: 010489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/04/2017
• Initial Date FDA Received: 05/26/2017
• Supplement Dates Manufacturer Received: Not provided; 06/27/2017
• Supplement Dates FDA Received: 06/23/2017; 07/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2004
• 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: 42 YR