MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE MRI SURESCAN; DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	6947M72
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	06/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: ddbb1d1 icd, implanted: (b)(6) 2018.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 oversensing with high rate non-sustained (hr-ns) and sensing integrity counter (sic) episodes.The patient was noted to have hydration issues during the hot summer.The rv lead was found to have t-wave oversensing (twos) causing false positive lia.The lead was reprogrammed and continues to be monitored.The lead remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: SPRINT QUATTRO SECURE MRI SURESCAN
• Common Device Name: DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8843058
• Report Number: 2649622-2019-13388
• Device Sequence Number: 14276569
• Product Code: NVY
• UDI-Device Identifier: 00643169309739
• UDI-Public: 00643169309739
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/30/2019

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: 06/16/2017
• Device Model Number: 6947M72
• Device Catalogue Number: 6947M72
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/30/2019
• 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: 6940-52 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Weight: 91