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

Device Problems High impedance (1291); Material Protrusion/Extrusion (2979); Positioning Problem (3009)

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

Event Date 11/24/2014

Event Type  malfunction  

Event Description

Clinic notes received on (b)(6) 2015 are dated (b)(6) 2014 and state that the patient may have displaced her lead.Lead protrusion was noted so vns advised.Notes dated (b)(6) 2015 state that the device has high impedance.There is no obvious case of high impedance and no adverse events associated with this high impedance follow-up for further information has been unsuccessful.Surgery is likely but has not occurred to date.

Manufacturer Narrative

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

Event Description

It was reported that the patient underwent generator and lead replacement due to high impedance.The generator was replaced due to suspected low battery.The explanted lead and generator have not been received for analysis to date.

• Brand Name: LEAD MODEL UNKNOWN
• Type of Device: LEAD
• 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: 4857122
• MDR Text Key: 5871858
• Report Number: 1644487-2015-04941
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/30/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 06/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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