MAUDE Adverse Event Report: MPRI CAPSURE VDD-2 LEAD; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number 5038

Device Problem Connection Problem (2900)

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

Event Date 12/15/2021

Event Type  Injury  

Event Description

It was reported that there was a connection issue between an implantable pulse generator (ipg) and an existing pacing lead approximately one day post implant of the ipg.A loose pin was suspected.Reprogramming was carried out.The ipg and pacing lead remain in use. no patient complications have been reported as a result of this event.

Manufacturer Narrative

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

• Brand Name: CAPSURE VDD-2 LEAD
• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• 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: 13188944
• MDR Text Key: 283390487
• Report Number: 2649622-2022-00371
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2022

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: 09/17/2004
• Device Model Number: 5038
• Device Catalogue Number: 5038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/07/2022
• Date Device Manufactured: 09/17/2002
• 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: ATDRS1 IPG
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Sex: Female