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

Model Number	E050
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Under-Sensing (1661)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
Boston scientific received information that there was two untreated episodes noted with this implantable cardioverter defibrillator (icd).Moreover, there were an undersensed beats noted.Boston scientific technical services (ts) then discussed adjusting sensitivity and suggested measuring the signal amplitude on the programmer.Ts also discussed could consider going back to nominal duration settings.Further, the ts explained that the device would not divert twice in a row.The icd remains in service.No adverse patient effects were reported.

• Brand Name: PUNCTUA ICD
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8534183
• Report Number: 2124215-2019-07146
• Device Sequence Number: 13831774
• Product Code: LWP
• UDI-Device Identifier: 00802526480676
• UDI-Public: 00802526480676
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2019

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: 01/15/2016
• Device Model Number: E050
• Device Catalogue Number: E050
• Device Lot Number: 100368
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 04/20/2019
• Patient Sequence Number: 1
• Patient Age: 48 YR