MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems High impedance (1291); Positioning Problem (3009)

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

Event Date 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This is a continuation of the reported high impedance associated with mfr.Report #1644487-2016-01582.The patient was undergoing generator replacement surgery on (b)(6) 2016, and high impedance was identified when the new generator was attached to the existing lead.The lead was then replaced, and the high impedance resolved.However, programming data from the surgery was reviewed, and there was evidence of incomplete pin insertion causing fluctuating impedance from normal to high impedance.Also, programming data from the patient's previous generator showed that there was no high impedance prior to the generator being replaced, and analysis of the lead showed evidence of possible incomplete pin insertion into the generator, as reported in mfr.Report #1644487-2016-01582.Therefore, the cause of the high impedance was incomplete pin insertion.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 6012967
• MDR Text Key: 78556225
• Report Number: 1644487-2016-02295
• 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
• Type of Report: Initial
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2018
• Device Model Number: 106
• Device Lot Number: 203771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2016
• 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: 8 YR