MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R; GENERATOR

Model Number 102R

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

Patient Problems Pain (1994); No Code Available (3191)

Event Date 03/09/2015

Event Type  Injury  

Event Description

It was reported by the patient that her generator was visible beneath her skin and that she was experiencing pain at her generator site because the skin over the generator was so thin.The patient mentioned that her device had been like this for two years.The patient's generator later migrated to her armpit and was causing her pain.No further relevant information has occurred to date.No surgical intervention has occurred to date.

Manufacturer Narrative

Initial report inadvertently listed aware date as 03/09/2017 instead of 03/10/2017.

Event Description

The nurse reported that the physician did not have an opinion about the protrusion or migration given the anatomical location the device had migrated to.The patient did not experience any trauma to the site that could have contributed to the generator protrusion and migration.The nurse mentioned that the protrusion was noticeable to the patient, but the patient never manipulated the generator.As such, the physician believed that the generator must have fallen down on its own.The physician planned to resolve the protrusion and migration during replacement surgery.The nurse indicated that the surgery was not required to preclude a serious injury and was for patient comfort.No further relevant information has occurred to date.No surgical intervention has occurred to date.

Manufacturer Narrative

Device evaluated by mfr? - device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.

Event Description

The patient underwent full revision surgery.The new generator was implanted in a different position to resolve the migration and protrusion that occurred with the now-explanted generator.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102R
• 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: 6452971
• MDR Text Key: 71484419
• Report Number: 1644487-2017-03543
• 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,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2008
• Device Model Number: 102R
• Device Lot Number: 015168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2006
• 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: 37 YR