MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem High impedance (1291)

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

Event Date 09/24/2014

Event Type  malfunction  

Event Description

It was reported that the recently implanted vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (impedance value = 10,000 ohms).System diagnostic showed lead impedance within normal limits during implant surgery on (b)(6) 2014 (impedance values ¿ 1653 ohms and 1585 ohms).The patient was admitted to the hospital on (b)(6) 2014 and the patient¿s device showed lead impedance within normal limits (impedance values ¿ 4632 ohms, 4306 ohms, and 4197 ohms).On (b)(6) 2014, the patient underwent surgery in which incomplete lead pin insertion was confirmed.After the pin was reinserted, system and generator diagnostic results showed normal device function.

• Brand Name: PULSE GEN MODEL 105
• 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: 4232000
• MDR Text Key: 5073368
• Report Number: 1644487-2014-02953
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/07/2014

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: 04/30/2016
• Device Model Number: 105
• Device Lot Number: 202965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/07/2014
• Initial Date FDA Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2014
• 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: 26 YR