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

Model Number 5076-52

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during the implant procedure, after 3 layers of closure of the pectoral pocket, noise oversensing was observed through the implantable cardioverter defibrillator (icd) on the atrial channel.Imaging indicated that the is1 pin of the atrial lead was not past the set screw block.The pocket was re-opened, and the atrial lead was reinserted into the header.It was verified that the lead pin was past the set screw block and closure of the pocket was started.After one layer of closure, again noise was observed.The pocket was re-opened, and the lead was removed and tested vis analyzer prior to reinsertion into the device header.All measurements were normal and again after pocket closer, noise was observed.This time, it was very difficult to back out the set screw to release the atrial lead from the header.A second wrench was used to loosen the set screw and the lead was again tested and all numbers were still within normal ranges.The decision was made to remove the icd due to potential set screw issues and new icd was connected to the lead and no issues were noted.The atrial lead remains in use.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: 9458980
• MDR Text Key: 170490659
• Report Number: 2649622-2019-23391
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00643169633759
• UDI-Public: 00643169633759
• 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: 12/12/2019

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: 09/10/2021
• Device Model Number: 5076-52
• Device Catalogue Number: 5076-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/12/2019
• Date Device Manufactured: 10/10/2019
• 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: DDMB1D4 ICD, 6935M62 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 15 YR
• Patient Weight: 70