MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PUNCTUA CRT-D; IMPLANTABLE DEVICE

Model Number	N051
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	04/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this patient presented to the emergency room (er) due to receiving shocks from their cardiac resynchronization therapy defibrillator (crt-d) device.Review of the device data indicated that the patient received device shocks two (2) days previously, a device interrogation was performed with a programmer and the device counters were reset.The patient then received additional device shocks and once again presented to the er.The healthcare provider (hcp) indicated that the patient received four (4) failed device shocks.Device therapy was not noted to have been exhausted.The corresponding stored episodes in which therapy was provided exhibited a non-sustained arrhythmia.Evidence suggests that the device shocks were provided due to an atrial-driven arrhythmia.The hcp indicated that they will be investigating the issue.The device remains in-service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.Pacing and sensing functions were tested, and the device was verified to operate as expected.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
This cardiac resynchronization therapy defibrillator (crt-d) device reached the elective replacement indicator (eri) and was subsequently explanted and replaced for normal battery depletion.The device was returned to boston scientific for analysis.This supplemental report is being filed based on completion of device analysis.

• Brand Name: PUNCTUA CRT-D
• Common Device Name: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10222094
• Report Number: 2124215-2020-11916
• Device Sequence Number: 2404205
• Product Code: LWP
• UDI-Device Identifier: 00802526480928
• UDI-Public: 00802526480928
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/26/2013
• Device Model Number: N051
• Device Catalogue Number: N051
• Device Lot Number: 100723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 11/05/2020
• Patient Sequence Number: 1
• Patient Age: 73 YR