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

Model Number 5076-45

Device Problem Connection Problem (2900)

Patient Problem Occlusion (1984)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 429888 lead, implanted: (b)(6) 2018; product id: w4tr03 crt-p, implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient's vein was occluded.The right ventricular (rv) pacing lead was removed to accommodate the new rv defibrillation lead.The new rv lead and chronic right atrial (ra) and left ventricular (lv) leads were connected to a new cardiac resynchronization therapy defibrillator (crt-d) where noise and low r-waves were observed on the right ventricular electrograms (egm).The new rv lead was removed from the crt-d and tested within normal limits via the analyzer.The lead was placed back in the crt-d header with the same oversensing noted.It was decided to utilize a second new device.The ra lead could not be removed from the device header as the setscrew would not release the lead.The ra lead was cut and capped and a new ra lead was placed.The new ra lead, new rv lead and chronic lv lead were connected to the second new device with no issues and remain 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: 10503753
• MDR Text Key: 205996764
• Report Number: 2649622-2020-17187
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00643169550759
• UDI-Public: 00643169550759
• Combination Product (y/n): Y
• 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
• Report Date: 09/08/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/06/2018
• Device Model Number: 5076-45
• Device Catalogue Number: 5076-45
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5076-52 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR