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

Model Number 103

Device Problems Coiled (1098); Component Falling (1105); Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 12/10/2015

Event Type  Injury  

Manufacturer Narrative

Event Description

On (b)(6) 2016 it was reported that the patient felt a lump and tension in the neck and generator site.This was reported as beginning the day after the last appointment on (b)(6) 2015.It is believed that the device may have migrated which was causing the difficulty interrogating the patient previously.It was noted that the patient was able to be successfully interrogated at this visit.Diagnostics were noted to be within normal limits and ifi-no.The patient has been referred to the surgeon for consult.The patient underwent a prophylactic replacement on (b)(6) 2016.The pre-op diagnostics were within normal limits and ifi-no.The patient had complaints of pulling sensation and migration of generator.The lead was reported to be uncoiled and the generator only was replaced.During surgery it had appeared that the generator had dropped in the chest and it looked like the lead was coiled almost as if the patient had manipulated the device but it was stated the patient did not.It was confirmed that non-absorbable sutures were used to secure the previous generator.The reported lump that the patient felt was determined to be the coiled lead in the chest.The lead pulling sensation was thought to be due to the generator dropping in the chest (reason is not known as manipulation or trauma is not suspected) and due to the lead being coiled (also reason unknown).The explanted generator has not been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 5413064
• MDR Text Key: 37555119
• Report Number: 1644487-2016-00238
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/03/2012
• Device Model Number: 103
• Device Lot Number: 2862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/13/2016
• Initial Date FDA Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2010
• 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): Required Intervention
• Patient Age: 68 YR