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

Model Number	693575
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); Fracture (1260); High impedance (1291); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); High Capture Threshold (3266)
Health Effect - Clinical Codes	Dyspnea (1816); Shock from Patient Lead(s) (3162)
Date of Event	07/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 407652 lead, implanted: (b)(6) 2005.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was inappropriately shocked by the right ventricular (rv) lead while asymptomatic and went to the emergency room (er).The rv lead triggered a lead integrity alert (lia) due to oversensing of noise with high rate non-sustained (hr-ns) and sensing integrity counter (sic) episodes.The lead had high impedance, high thresholds with loss of capture, and a confirmed fracture.A magnet was placed over the device to prevent any further shocks and the lead was programmed off.The lead remains in the patient out of service.It was further reported that the right atrial (ra) lead has high thresholds.The lead remains in use.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 associated with the right ventricular lead.Analysis of the device memory indicated the criteria for the right ventricular lead integrity alert were met.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 oversensing due to non-physiologic signals/sensing integrity counter.Analysis of the device memory indicated unexpected delivery of ventricular tachyarrhythmia therapy.If information is provided in the future, a supplemental report will be issued.
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 later presented to the er again with shortness of breath.Upon review of the device interrogation, therapies and the rv lead were programmed off into an atrial only mode.

• 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: 7801940
• Report Number: 2649622-2018-13673
• Device Sequence Number: 228855
• Product Code: LWS
• UDI-Device Identifier: 00613994446367
• UDI-Public: 00613994446367
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2019

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: 10/25/2012
• Device Model Number: 693575
• Device Catalogue Number: 693575
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 08/21/2018; 10/05/2019
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 09/13/2018; 10/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0474-2011
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DDMB1D1 ICD
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR