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

Model Number 105

Device Problems Impedance Problem (2950); Positioning Problem (3009)

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

Event Date 06/20/2014

Event Type  malfunction  

Manufacturer Narrative

Event Description

An explanted generator and lead were returned to the manufacturer for analysis in mfr.Report # 1644487-2015-05052.Product analysis was completed for the lead.No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time.It appears that the incomplete pin insertion condition existed during the time of implant, as no other sets of setscrew marks were observed on the connector pin surface.There was no evidence to suggest an anomaly with the returned portion of the device.Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Product analysis was completed for the generator.There were no performance or any other type of adverse conditions found with the pulse generator.It was found that impedance increased from 2268 ohms to 5717 ohms on approximately (b)(6) 2015.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5102882
• MDR Text Key: 26916915
• Report Number: 1644487-2015-05884
• 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
• Reporter Occupation: Other
• Report Date: 08/28/2015

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: 12/13/2015
• Device Model Number: 105
• Device Lot Number: 202801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2014
• 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: 43 YR