MAUDE Adverse Event Report: MPRI CAPSUREFIX NOVUS LEAD MRI SURESCAN; ELECTRODE, PACEMAKER, PERMANENT

Model Number 5076-52

Device Problem Connection Problem (2900)

Patient Problem Dyspnea (1816)

Event Date 03/09/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Concomitant medical products: 693565 lead, implanted: (b)(6) 2010.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was brought into the clinic due to complaints of shortness of breath.An interrogation noted that the right atrial (ra) lead and competitor left ventricular (lv) lead may have been transposed in the header of the device.A revision was performed that confirmed the leads were transposed.The ra lead and lv lead were disconnected and connected into the correct ports.Sensing, impedance, and threshold were tested and confirmed that the leads were pacing and sensing the correct portion of the heart.The ra lead remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: CAPSUREFIX NOVUS LEAD MRI SURESCAN
• Type of Device: ELECTRODE, PACEMAKER, PERMANENT
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9897105
• MDR Text Key: 185627205
• Report Number: 2649622-2020-06558
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00681490124812
• UDI-Public: 00681490124812
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/20/2012
• Device Model Number: 5076-52
• Device Catalogue Number: 5076-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DTMA1D1 CRT-D, 511211 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR