MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problems Material Frayed (1262); Cut In Material (2454); Low Battery (2584)

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

Event Date 09/26/2016

Event Type  malfunction  

Event Description

The patient was undergoing a generator replacement due to battery depletion when it was observed that in the middle of portion of the lead the lead tubing was frayed.It appeared that there was slit in the tubing; however, it was not believed to have occurred during the surgery.Pre-op diagnostic testing showed that the lead impedance was within acceptable limits.The lead being frayed was only identified once the pocket was open.The lead and generator were then replaced.The explanted lead and generator have not been received to date.

Event Description

The explanted lead and generator were received and are currently pending product analysis.

Event Description

Product analysis was completed on the explanted generator and lead.Analysis on the generator showed that the generator performed according to functional specifications.The internal data of the generator was reviewed and noted that the last >25% change in impedance occurred on the day after explant on (b)(6) 2016.The prechange value was 4281 ohms and the postchange value was 20,519 ohms.It was noted that the lead was received in 4 portions.No discontinuities were identified within the returned lead portions.Sem imaging did observe pitting on the positive coil end of one of the portions of the lead.However it appeared that the likely cause of this pitting was the generator being left programmed on at the time of explant.Visual analysis found that the outer silicone tubing had abrasions and a compressed appearance at multiple locations.In one of the returned portions of the lead there were abrasions in the inner tubing but no evidence of pitting was observed in that portion of the lead.Analysis found that the likely cause of the abrasions were related to structural wear on the lead.

• Brand Name: LEAD MODEL 304
• 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: 6025472
• MDR Text Key: 57332520
• Report Number: 1644487-2016-02348
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2013
• Device Model Number: 304-20
• Device Lot Number: 2423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2009
• 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: 12 YR