MAUDE Adverse Event Report: MPRI CAPSURE EPICARDIAL LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 4968-35

Device Problems Failure to Capture (1081); Connection Problem (2900); Impedance Problem (2950); Unstable Capture Threshold (3269)

Patient Problem Dizziness (2194)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: ddpb3d1 icd, implanted: (b)(6) 2021.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that two days post the implantable cardioverter defibrillator (icd) change out procedure there was loss of atrial capture on the right atrial (ra) lead causing the patient to experience light headedness.It was also noted that the atrial thresholds had become very unstable and the impedance started rising post change out.A revision was performed were the ra lead was reinserted into the atrial port fully.The icd and ra lead remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: CAPSURE EPICARDIAL LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: 12494997
• MDR Text Key: 272135921
• Report Number: 2649622-2021-19087
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00613994492302
• UDI-Public: 00613994492302
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950024
• 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: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/18/2015
• Device Model Number: 4968-35
• Device Catalogue Number: 4968-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2021
• Date Device Manufactured: 05/22/2013
• 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: 4968-35 LEAD, 6937A-52 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 70