MAUDE Adverse Event Report: MPRI SPRINT QUATTRO LEAD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	6944-65
Medical Device Problem Codes	Over-Sensing (1438); High Capture Threshold (3266)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the right atrial (ra) lead has been exhibiting high thresholds.It was also noted that the right ventricular (rv) lead exhibited high threshold a couple of months ago and prior to that.The ra lead and rv lead remain in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the right ventricular (rv) lead experienced three prior episodes of t-wave oversensing (twos) as noted on the stored electrogram; one of which appeared as a high rate non-sustained episode.It was noted that no further twos episodes were observed.

• Brand Name: SPRINT QUATTRO LEAD
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7417100
• Report Number: 2649622-2018-04645
• Device Sequence Number: 1083885
• Product Code: LWS
• UDI-Device Identifier: 00643169451469
• UDI-Public: 00643169451469
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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: 03/09/2018
• Device Model Number: 6944-65
• Device Catalogue Number: 6944-65
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2018
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DDBB1D1 ICD, 457453 LEAD
• Patient Age: 45 YR