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

Model Number 5076-58

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: w3dr01 ipg, implanted on (b)(6) 2021.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician was unable to insert lead into the new header of the device.The lead would not pass at the silicone junction of the lead pin.The pacing lead was capped and replaced.No 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: 11818131
• MDR Text Key: 250396300
• Report Number: 2649622-2021-09590
• Device Sequence Number: 1
• Product Code: DTB
• 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
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2012
• Device Model Number: 5076-58
• Device Catalogue Number: 5076-58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2021
• Date Device Manufactured: 12/20/2010
• 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: 5076-52 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR