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

Model Number	5071-25
Medical Device Problem Codes	Low impedance (2285); High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2017
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 that the patient's right ventricular (rv) lead and right atrial (ra) lead exhibited high thresholds.It was further noted that the implantable pulse generator (ipg) battery longevity estimator measurement was not available, however, the battery voltage was available.The device and leads remain 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 low impedance was noted on the ra lead and rv leads.The longevity estimate was low on the ipg.The ipg and leads remains in use.

• 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: 7255866
• Report Number: 2649622-2018-01425
• Device Sequence Number: 16433769
• Product Code: DTB
• UDI-Device Identifier: 00681490124300
• UDI-Public: 00681490124300
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P120017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2019

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: 06/14/2016
• Device Model Number: 5071-25
• Device Catalogue Number: 5071-25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 11/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR