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

Model Number	N051
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	06/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was noise on the right ventricular (rv) lead that was sensed and resulted in inappropriate anti-tachycardia pacing and shock therapy, along with multiple non-sustained ventricular episodes.The rv pace impedance was also greater than 2,500 ohms.At this time the cardiac resynchronization therapy defibrillator and rv lead (non-boston scientific product) remain in service and no adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent fluctuations in impedance measurements with no conclusive evidence of a product malfunction; please refer to the event description for more information regarding the specific circumstances of this event.
Event or Problem Description
It was reported that there was noise on the right ventricular (rv) lead that was sensed and resulted in inappropriate anti-tachycardia pacing and shock therapy, along with multiple non-sustained ventricular episodes.The rv pace impedance was also greater than 2,500 ohms.At this time the cardiac resynchronization therapy defibrillator and rv lead (non-boston scientific product) remain in service and no adverse patient effects were reported.

• 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: 12164193
• Report Number: 2124215-2021-19028
• Device Sequence Number: 11726748
• Product Code: LWP
• UDI-Device Identifier: 00802526480928
• UDI-Public: 00802526480928
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2021

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: 01/24/2016
• Device Model Number: N051
• Device Catalogue Number: N051
• Device Lot Number: 101401
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 10/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR