MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Failure to Interrogate (1332); Battery Problem (2885)

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

Event Date 03/03/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device could not be interrogated.Generator replacement surgery was scheduled due to suspected end of service.Additional information was received stating that the neurosurgeon¿s wand battery needed to be replaced.After the battery was replaced, the wand was functioning properly which indicates that the wand battery likely caused the failure to communicate.Additionally, the doctor¿s office planned to contact the patient to inform him surgery was no longer required.With the available information, no definitive conclusions can be made.The patient has not been seen to confirm that the generator could be communicated with since the initial report.Review of the available programming history showed that the last known settings were from (b)(6) 2013.

Manufacturer Narrative

Device manufacturing records and available programming and diagnostic history were reviewed.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

Event Description

It was reported that the patient was seen by the physician and the device was successfully interrogated.The battery status was reported to be at ifi=yes on (b)(6) 2015.The patient was referred for prophylactic battery replacement.The patient underwent prophylactic generator replacement on (b)(6) 2015.Explanted product has not been received to-date.

Manufacturer Narrative

Evaluation codes, corrected data: the evaluation conclusion code inadvertently was reported on the initial report.

Event Description

It was reported that the battery was at near end-of-service = no.The explanted generator was discarded and will not be returned for analysis.

• Brand Name: PULSE GEN MODEL 103
• 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: 3710780
• MDR Text Key: 4333282
• Report Number: 1644487-2014-00831
• 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,Followup
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2013
• Device Model Number: 103
• Device Lot Number: 201683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2011
• 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: 28 YR