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

Model Number 302-20

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

Patient Problem No Code Available (3191)

Event Date 07/17/2014

Event Type  malfunction  

Event Description

It was reported that during generator replacement for battery depletion, high impedance was observed with the new generator attached to the existing lead.The patient was referred for lead replacement at a later time.An implant card was received indicating high impedance.The explanted generator for analysis.Analysis was completed on (b)(4) 2014.The device performed according to functional specifications.Therefore, the electrical performance of the generator, as measured in the pa lab, will be used to conclude that no abnormal performance or any other type of adverse condition was found with the generator.The patient underwent lead replacement.It was reported that device diagnostics with the new lead and existing generator was within normal limits (1275 ohms).The explanted lead has not been received for analysis to date.

Event Description

The explanted lead has been returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative

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

Event Description

Analysis of the returned lead portion was completed.During the visual analysis, the coil appeared to be broken and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no pitting.Pitting was observed on the coil surface.The slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing.With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.

Manufacturer Narrative

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

• Brand Name: LEAD MODEL 302
• 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: 4074618
• MDR Text Key: 4741532
• Report Number: 1644487-2014-02289
• 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: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2005
• 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: 51 YR