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

Model Number 102

Device Problems High impedance (1291); Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Date 11/23/2009

Event Type  malfunction  

Event Description

It was reported that the vns patient was experiencing pain at his electrode site.The patient¿s device was disabled and the patient was admitted to the hospital for x-rays and further evaluation.The patient¿s physician stated that the patient¿s pain was related to vns.Follow-up revealed that the patient¿s device was disabled because it showed high impedance (dc dc ¿ 7).The patient reported that his pain had improved and was intermittent.The patient was referred for surgery but no known surgical interventions have occurred to date.X-rays dated (b)(6) 2014 were provided to the manufacturer for further review.The generator appears in the left chest in a normal placement.The filter feed-through wires appear to be intact.The lead connector pin does not appear to be fully inserted into the generator connector block.The electrodes appeared to be placed in normal arrangement.Part of the lead was behind the generator and could not be assessed.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.Based on the images provided, high lead impedance may be due to incomplete lead pin insertion.Review of the available programming and diagnostic history showed normal diagnostic results on the date of implant.

Event Description

Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014.The replacement generator was tested with the existing lead and diagnostics showed lead impedance within normal limits (impedance value ¿ 3784 ohms).As result, no lead issue was suspected and the reported high impedance was believed to be due to incomplete lead pin insertion.The explanted generator has not been returned to date.

Manufacturer Narrative

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

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• 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: 4095469
• MDR Text Key: 4720437
• Report Number: 1644487-2014-02358
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2011
• Device Model Number: 102
• Device Lot Number: 2353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2009
• 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: 33 YR