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

Model Number 102

Device Problem High impedance (1291)

Patient Problem Pain (1994)

Event Date 09/28/2006

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in high impedance (dc dc code - 7).It was reported that the patient experiences painful stimulation that started two weeks prior.The patient has not experienced any trauma to the neck area.The neurologist reviewed x-rays and reported that nothing unusual was noted.The patient was referred for surgery.The physician reported that the device was programmed off after observing the high impedance.The physician reported that x-rays would not be sent to manufacturer for review.Surgical intervention has not occurred to date.

Event Description

Additional information was received indicating that the vns patient¿s generator replacement resolved reported high impedance.The replacement device was tested with the existing lead multiple times and showed lead impedance within normal limits.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Date of event, corrected data: supplemental manufacturer report #01 inadvertently did not update this information.Operator of device, corrected data: supplemental manufacturer report #01 inadvertently did not update this information.

Event Description

It was reported that the patient underwent surgery and that only the generator was replaced.It was reported that the generator was discarded after the surgery and would not be received for analysis.Attempts to obtain additional relevant information have been unsuccessful to date.It appears that the high impedance resolved with generator replacement since only the generator was replaced indicating a likely generator/lead connection problem.

Manufacturer Narrative

New information changes the suspect device.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3761805
• MDR Text Key: 4550578
• Report Number: 1644487-2014-01069
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2007
• Device Model Number: 102
• Device Lot Number: 012303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2005
• 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: 54 YR