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

Model Number 103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 10/14/2016

Event Type  Injury  

Event Description

The patient underwent battery replacement on (b)(6) 2016 due to reported battery depletion.Explant notes for the patient's generator explant in 2016 were received and indicated that the generator was flipped and turned and the wires were coiled in a twisted manner into a knot.This was able to be un-round and untied.After explant, it was stated the 106 was then secured more efficiently with silk sutures.A lead test was performed and showed good impedance 2309 ohms.While the notes don¿t indicate that the reason for surgery was due to the device migration (patient was referred due to low battery), the notes do state that this was a more difficult than usual procedure due to findings of the wires and generator twisting resulting in extra time to unwind and inspect the wires and electrode connector.No additional information has 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8562074
• MDR Text Key: 143461630
• Report Number: 1644487-2019-00820
• 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: Physician
• Type of Report: Initial
• Report Date: 04/29/2019

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: 12/06/2012
• Device Model Number: 103
• Device Lot Number: 201689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2011
• 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): Required Intervention
• Patient Age: 28 YR