MAUDE Adverse Event Report: MPRI ATTAIN BIPOLAR OVER THE WIRE LEAD; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number 419488

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 04/03/2024

Event Type  Injury  

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed valid.Continuation of d10: dtba1d1, crt-d implanted: (b)(6) 2019; medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported that during use of the left ventricular (lv) lead, the patient experienced side pain when lead was pacing.  the lv lead was capped and a new lead was implanted.  the lv lead remains in the patient.  no further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN BIPOLAR OVER THE WIRE LEAD
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 19166766
• MDR Text Key: 340861446
• Report Number: 2649622-2024-11225
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00885074113371
• UDI-Public: 00885074113371
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

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: 07/26/2008
• Device Model Number: 419488
• Device Catalogue Number: 419488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/23/2024
• Date Device Manufactured: 08/01/2006
• 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, 693165 LEAD.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male