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

Model Number	383074
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 pacing threshold increased, and there was no change in pacing impedance or r-wave amplitude.The decision was made to add a lead near the original and keep the rv lead connected to a cardiac resynchronization therapy pacemaker (crt-p) device in order to maintain magnetic resonance imaging (mri) compatibility.The lead was placed in the left ventricular (lv) lead port and is currently not being utilized for pacing.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.

• Brand Name: SELECTSECURE
• 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: 7695230
• Report Number: 2649622-2018-11628
• Device Sequence Number: 646029
• Product Code: NVN
• UDI-Device Identifier: 00643169535855
• UDI-Public: 00643169535855
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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: 06/29/2018
• Device Model Number: 383074
• Device Catalogue Number: 383074
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 10/05/2018
• 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, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR