MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G141

Device Problem Migration (4003)

Patient Problem Muscle Stimulation (1412)

Event Date 11/28/2019

Event Type  malfunction  

Event Description

It was reported that this patient has experienced episodes of phrenic nerve stimulation (pns) since the device implant procedure.The physician has reprogrammed the device multiple times since implant as an attempt to relieve the pns, but the patient still has complaints of undesired sensations.Upon diagnostic imaging, the physician observed tremors from the system.Boston scientific technical services were contacted and confirmed the observed small migratory movement of the device does not match the delivered pacing rate, but could not conclusively exclude device involvement.The physician is considering explanting the system, but at this time, the device remains implanted.The patient was stable with no additional adverse consequences.Additional information has been requested regarding resolution, but not yet received.

• Brand Name: INOGEN CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9628831
• MDR Text Key: 176305130
• Report Number: 2124215-2019-28528
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534553
• UDI-Public: 00802526534553
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2021
• Device Model Number: G141
• Device Catalogue Number: G141
• Device Lot Number: 136547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1