MAUDE Adverse Event Report: MPRI SELECTSECURE MRI SURESCAN; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number	383074
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	Muscle Weakness/Atrophy (1967)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 407645 lead implant date (b)(6) 2011.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient presented to hospital with weakness.The right ventricular (rv) his bundle lead exhibited high v-v sensing integrity counter (sic) count.The rv his lead remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: SELECTSECURE MRI SURESCAN
• Common Device Name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 11788775
• Report Number: 2649622-2021-09155
• Device Sequence Number: 3846383
• Product Code: NVN
• UDI-Device Identifier: 00643169535855
• UDI-Public: 00643169535855
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P030036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/07/2021

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: 04/11/2019
• Device Model Number: 383074
• Device Catalogue Number: 383074
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/07/2021
• 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: A2DR01 IPG
• Patient Age: 83 YR
• Patient Weight: 75