MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COGNIS; IMPLANTABLE DEVICE

Model Number N119

Device Problem Delayed Charge Time (2586)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2022

Event Type  malfunction  

Event Description

It was reported that a boston scientific field representative was directed to program device therapy off for this cardiac resynchronization therapy defibrillator (crt-d) device based on a physicians order due to the patients age and the patients wishes.When the representative interrogated the device, a code 1007 was observed.A code 1007 indicates that the device capacitor charge time exceeded the 45 second limit.The device was also noted to have reached end of life (eol) status due to normal battery depletion.Boston scientific technical services (ts) discussed the code 1007 with the representative and provided guidance to evaluate the crt-d system further.Device therapy was subsequently programmed off and no further actions were taken.The device remains implanted.There were no patient symptoms or adverse patient effects.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: COGNIS
• Type of Device: IMPLANTABLE DEVICE
• 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: 15996825
• MDR Text Key: 307933136
• Report Number: 2124215-2022-53198
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/06/2012
• Device Model Number: N119
• Device Catalogue Number: N119
• Device Lot Number: 471105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female