MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R; GENERATOR

Model Number 102R

Device Problems High impedance (1291); Difficult to Remove (1528)

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

Event Date 06/27/2013

Event Type  malfunction  

Event Description

During review of programming and diagnostic history, it was observed that the vns patient's device was tested during an office visit on (b)(6) 2013 and system diagnostic results revealed high impedance (dc dc -4).The device was tested again during an office visit on (b)(6) 2015 and system diagnostic results again showed a high impedance condition (dcdc - 7).No patient adverse events were reported.No known surgical interventions have occurred to date.No x-ray images can be obtained from the site.

Event Description

It was reported that the patient had a generator replacement surgery.The surgeon had some difficulty removing the lead pin from the generator and no corrosion was observed.Additional information was received from the surgeon's office that during generator replacement surgery for this patient the doctor unscrewed the screws, and the lead usually just slides right out, but the top pin would not come out.The bottom pin looked like it would come right out, and did not appear to be stuck, like the top lead pin.The doctor then took the screw all the way out, and looking through the screw hole, was able to observe that the pin was in at a slight angle, so pulling the pin out directly was not working, and was keeping the lead from coming out.Therefore the doctor took a pair of blunt mosquito forceps and twisted and cracked the top part of the generator where the lead was inserted.When the generator was cracked, they were able to remove the lead.When they observed the lead pins after taking it out of the generator, the lead did not look bent at all, but looked perfectly fine.They replaced the generator with a new generator, inserted the lead and ran diagnostics several times, each time with a good outcome where the results were within normal limits, and lead impedance was ok.The nurse believed the poor diagnostics from the explanted generator was probably due to the connection between the lead pin and the generator due to the fact that the lead pin was so difficult to pull out.The device was discarded after surgery.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102R
• Type of Device: GENERATOR
• 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: 5242913
• MDR Text Key: 32200557
• Report Number: 1644487-2015-06507
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

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: Health Professional
• Device Expiration Date: 01/31/2014
• Device Model Number: 102R
• Device Lot Number: 202009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/23/2015
• Supplement Dates Manufacturer Received: 09/29/2017
• Supplement Dates FDA Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2012
• 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: 50 YR