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

Model Number	6935M72
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439); Decreased Sensitivity (2534)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: dtmb1qq crt-d, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that an in-office check found that the right ventricular (rv) lead had very small r-waves.There had also been significant episodes of t-wave oversensing (twos) earlier in the month of which the t-wave discrimination feature applied and kept the patient from getting inappropriate shocks.It was noted that due to the t-wave oversensing post vs (ventricular sensed) there was a loss of crt (cardiac resynchronization therapy) pacing.The rv lead was reprogrammed and remains in use.No patient complications have been reported as a result of this event.

• Brand Name: SPRINT QUATTRO SECURE S
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8153473
• Report Number: 2649622-2018-20418
• Device Sequence Number: 252418
• Product Code: LWS
• UDI-Device Identifier: 00613994718877
• UDI-Public: 00613994718877
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/28/2015
• Device Model Number: 6935M72
• Device Catalogue Number: 6935M72
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Weight: 87