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

Model Number	6947M72
Medical Device Problem Codes	Break (1069); Pacing Problem (1439); Impedance Problem (2950)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2020
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 by the patient that the right ventricular (rv) lead exhibited rising "amperage," and the patient suspected that the lead was "breaking down." 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 by the patient's physician that the lead issue was increased impedance and pacing.

• 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: 9806724
• Report Number: 2649622-2020-04847
• Device Sequence Number: 610080
• Product Code: NVY
• UDI-Device Identifier: 00643169082281
• UDI-Public: 00643169082281
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/12/2014
• Device Model Number: 6947M72
• Device Catalogue Number: 6947M72
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 03/31/2020
• 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: D314VRM ICD
• Patient Age: 69 YR
• Patient Weight: 85