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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem Scar Tissue (2060)

Event Date 11/08/2016

Event Type  malfunction  

Event Description

During a patient's generator replacement due to battery depletion, high impedance was identified post-operatively.No pre-op diagnostics were performed with the explanted generator due to normal battery depletion.The generator was tested pre-operatively and operated as expected.The lead pin was also reportedly visualized past the connector block.The surgeon could not perform lead replacement surgery due to the scar tissue at the patient's neck.The lead portions were reportedly discarded after explant.The physician indicated that he did not see any gross discontinuities when visually analyzing the lead and that the scar tissue was expected.

Event Description

It was reported that both devices were discarded after the patient's surgery (generator and lead).Additionally, it was verified that a new generator was not implanted during the patient's surgery.

Event Description

The explanted generator that was previously thought to be discarded was returned for product analysis, but the explanted lead was not returned.

Event Description

The generator was returned for product analysis (pa) and the reported end of service condition was verified in the pa lab.Measurement of the battery voltage determined that the battery was depleted and when tested on the bench analysis, it verified that the consumption rates were within specifications.

• 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: 6129412
• MDR Text Key: 61249148
• Report Number: 1644487-2016-02736
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/17/2017

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
• Device Expiration Date: 09/30/2008
• Device Model Number: 302-20
• Device Lot Number: 1283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 11/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/13/2016; 01/10/2017; 01/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2005
• 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: 66 YR