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

Model Number	6935M49
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Shock from Patient Lead(s) (3162)
Date of Event	09/25/2018
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 a lead integrity alert (lia) triggered for varying impedance and elevated sensing integrity counter (sic).The lead remains 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 further reported that the lead was reprogrammed and remains in use.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that the patient received inappropriate therapy.The lead exhibited oversensing-noise and high defibrillation impedance.Therapies for the lead were turned off and the patient is now wearing a wearable defibrillator vest.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated oversensing due to non-physiologic signals/sensing integrity counter.Analysis of the device memory indicated the impedance of the right ventricular pacing lead was beyond the expected upper range.Analysis of the device memory indicated the impedance trend of the right ventricular pacing lead was variable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that the lead exhibited high pacing impedance and was suspected of being fractured.The lead was reprogrammed, remains in use, and the patient is being monitored.

• Brand Name: SPRINT QUATTRO SECURE S MRI SURESCAN
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7995327
• Report Number: 2649622-2018-17279
• Device Sequence Number: 13560046
• Product Code: LWS
• UDI-Device Identifier: 00613994808004
• UDI-Public: 00613994808004
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/20/2019

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: 09/28/2015
• Device Model Number: 6935M49
• Device Catalogue Number: 6935M49
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 09/25/2018; 09/25/2018; 09/25/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 10/26/2018; 03/25/2019; 09/20/2019
• 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: (B)(4)
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 16 YR