MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COGNIS; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number N119

Device Problem Defective Device (2588)

Patient Problems Syncope (1610); Head Injury (1879); Cognitive Changes (2551); No Code Available (3191); Syncope/Fainting (4411)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).This device was not returned as records indicate it was retained by the explanting hospital.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) would not interrogate.It was suspected that the crt-d had depleted, as it had been implanted in (b)(6) 2009.It was possible that the patient was lost to follow-up.The patient presented to the emergency room (er) due to syncope with head injury, and the patient had an altered mental state.The next day, the crt-d was explanted, and normal battery depletion (nbd) was noted.A new crt-d was successfully implanted.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) would not interrogate.It was suspected that the crt-d had depleted, as it had been implanted in august 2009.It was possible that the patient was lost to follow-up.The patient presented to the emergency room (er) due to syncope with head injury, and the patient had an altered mental state.The next day, the crt-d was explanted, and normal battery depletion (nbd) was noted.A new crt-d was successfully implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

This device was not returned as records indicate it was retained by the explanting hospital.If information is provided in the future, a supplemental report will be issued.

• Brand Name: COGNIS
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11234058
• MDR Text Key: 228836345
• Report Number: 2124215-2021-02325
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/06/2010
• Device Model Number: N119
• Device Catalogue Number: N119
• Device Lot Number: 180867
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 02/17/2021
• Supplement Dates FDA Received: 04/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR