MAUDE Adverse Event Report: MPRI MYOCARDIAL LEAD; ELECTRODE, PACEMAKER, PERMANENT

Model Number	5071-25
Medical Device Problem Codes	Over-Sensing (1438); High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a healthcare professional (hcp) phoned in to inquire about potential lead optimization of the patients right ventricular (rv) epicardial lead that was oversensing, which resulted in double-counting r-waves.High capture threshold was also noted on the rv lead.Programming options were discussed, but it is unclear if any programming optimization was completed.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.

• Brand Name: MYOCARDIAL LEAD
• Common Device Name: ELECTRODE, PACEMAKER, PERMANENT
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6468582
• Report Number: 2649622-2017-03610
• Device Sequence Number: 591019
• Product Code: DTB
• UDI-Device Identifier: 00681490124300
• UDI-Public: 00681490124300
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P120017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2017

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: 04/28/2018
• Device Model Number: 5071-25
• Device Catalogue Number: 5071-25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2017
• Supplement Date Received by Manufacturer: 01/20/2017
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR