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

Model Number 302-20

Device Problems High impedance (1291); Low Battery (2584); Output Problem (3005)

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

Event Date 08/30/2016

Event Type  malfunction  

Event Description

It was reported that vns patient¿s system showed a high impedance during a clinical visit, the lead was implanted 6 years ago.The results of the generator diagnostic are : output current status low / current delivered 0.75ma/ lead impedance high (7164 ohms) / intensified follow up indicator = yes).The programmed settings are 2.75 ma output current / 30 hz frequency / 500usec pulse width/ 7sec on time / 0.3 min off time.Low battery was also observed but considered as normal expected status due to the high settings and the suspected high impedance.The review of the manufacturing records confirmed all tests passed for the lead and the generator prior to distribution.

Event Description

Follow up indicated that no trauma or manipulation occurred for the patient, the device is still on.There is no intervention done for this patient.It was also reported that x-ray was performed to check the lead and showed that there is breakage in that lead but they don't have the copy any more.A copy of the programming data of the patient was provided to the manufacturer.Further review of the decoded data from the device indicated that the high impedance occurred on (b)(6) 2016.An increase in the percentage of the used battery capacity was observed, this occurred due to the presence of the lead break.A fluctuation on battery voltage was noted that is most likely linked to the low battery status.

Manufacturer Narrative

This information was inadvertently left off on mfg.Report #1.

Event Description

An implant card was received which indicated that the patient underwent lead and generator replacement surgery due to the high impedance.The explanted products have not been received to date.

Event Description

It was reported that the explanted lead and generator were not available for return.

• 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: 5986222
• MDR Text Key: 56542155
• Report Number: 1644487-2016-02227
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/09/2017

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: 10/31/2013
• Device Model Number: 302-20
• Device Lot Number: 201233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/05/2016
• Initial Date FDA Received: 09/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/02/2016; 01/12/2017; 02/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2009
• 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: 27 YR