MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 12/01/2014

Event Type  Injury  

Event Description

It was reported that the patient was referred for a repositioning surgery due to migration of the generator.The generator had moved to the shoulder and clavicle and was causing pain.Over the past several weeks the patient has complained of left shoulder and clavicle pain.It is almost constant and is particularly brought on by weight lifting and other movements.The patient participates in very strenuous activities and the surgeon believes that these activities caused the generator to break through the encapsulation and migrate upward.System diagnostics were performed which showed the device to be functioning properly, with an impedance value of 2339ohms.The surgeon brought the patient in on (b)(6) 2014 to reposition it lower to help with discomfort.

Manufacturer Narrative

• Brand Name: PULSE GEN MODEL 103
• 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: 4401903
• MDR Text Key: 5124497
• Report Number: 1644487-2015-03577
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2013
• Device Model Number: 103
• Device Lot Number: 201739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2011
• 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 Outcome(s): Other
• Patient Age: 23 YR