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

Model Number	693558
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: dtbb1d1 icd, implanted: (b)(6) 2015.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 triggered a lead integrity alert (lia) for high impedance on the superior vena cava (svc) coil and oversensing of noise with high rate non-sustained (hr-ns), ventricular tachycardia non-sustained (vt-ns), and sensing integrity counter (sic) episodes.The lead was reprogrammed and remains in use.It was further reported that the left ventricular (lv) lead has a high increasing threshold that was greater than the programmed safety margin.The lead remains in use.The patient will follow up with the physician for further evaluation.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: 7825685
• Report Number: 2649622-2018-14116
• Device Sequence Number: 19444706
• Product Code: LWS
• UDI-Device Identifier: 00643169535909
• UDI-Public: 00643169535909
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/29/2018

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: 12/14/2017
• Device Model Number: 693558
• Device Catalogue Number: 693558
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/29/2018
• 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: 4194-88 LEAD, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR