MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Code Available (3191)

Event Date 06/18/2015

Event Type  malfunction  

Event Description

It was reported that during the patient's exploration surgery, electrocautery was used and may have touched the patient's generator, causing an asic latch-up condition, resulting in premature end of battery life.Pre-operative diagnostics yielded neos=no, but after the generator was re-positioned in the patient, diagnostics read neos=yes.The surgeon stated that he did not strike the generator with electrocautery.The generator was replaced.The explanted generator has been received by the manufacturer for analysis.However, analysis has not been completed to date.

Event Description

Analysis of the explanted generator was completed.Review of the data downloaded from the generator indicated that the pulse had been disabled by the generator.Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device explant, which may have been a contributing factor.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, 3.139 volts as measured during completion of the final electrical test, shows an ifi=no condition.Other than the noted pulse disabled event, there were no additional performance or any other type of adverse condition found with the pulse generator.An fda medwatch 3500a form was received by the manufacturer from the user facility regarding this event, stating that the device did not perform as intended (uf/importer report # 3902560000-2015-8031).

• Brand Name: PULSE GEN MODEL 105
• 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: 4902167
• MDR Text Key: 21184038
• Report Number: 1644487-2015-05117
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: 105
• Device Lot Number: 202832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2015
• Is the Reporter a Health Professional?: No
• Device Age: 231 DY
• Event Location: Operating Room
• Date Manufacturer Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2014
• 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: 41 YR