MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number G141

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)

Patient Problem Electric Shock (2554)

Event Date 02/05/2023

Event Type  malfunction  

Event Description

It was reported that cardiac resynchronization therapy defibrillator (crt-d) had triggered code 1007 due to the capacitor charge time exceeding limitations along with the battery capacity being depleted.A code 1004 was suspected, which was indicative of a short circuit condition.Additionally, the patient indicated that received some electric shocks.Troubleshooting options were discussed and recommended.At this time, the crt-d remains in service and no adverse patient effects were reported.

• Brand Name: INOGEN CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 16436215
• MDR Text Key: 310162884
• Report Number: 2124215-2023-08677
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/25/2017
• Device Model Number: G141
• Device Catalogue Number: G141
• Device Lot Number: 110378
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2015
• 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 Age: 73 YR
• Patient Sex: Female