MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problems High impedance (1291); Battery Problem (2885)

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

Event Date 06/23/2015

Event Type  malfunction  

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description

Following generator replacement surgery for normal end of service, high impedance was observed.It was reported that device diagnostics were unable to be run prior to the surgery because the generator battery was completely depleted.The surgeon indicated that he wanted the device programmed on and to follow-up with the patient in 3 weeks.No known surgical interventions have occurred to date to correct the high impedance.No additional relevant information had been received to date.

Manufacturer Narrative

The information was incorrectly reported on the initial mfr.Report.

Event Description

Lead revision surgery took place on (b)(6) 2015 due to the high impedance found.It was noted that the lead appeared to have a clean cut during the surgery, which would likely have contributed to the high impedance found.It is unknown how or when the lead first became severed.Once the lead was replaced, system diagnostics were run again and were within acceptable limits.It was reported that the lead was discarded at the hospital and will not be returned for analysis.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: 4922247
• MDR Text Key: 22476056
• Report Number: 1644487-2015-05201
• Device Sequence Number: 1
• Product Code: MUZ
• 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,health
• Reporter Occupation: Other
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2005
• 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: 64 YR