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

Model Number 5038-58

Device Problems Failure to Capture (1081); Electromagnetic Interference (1194); Over-Sensing (1438); Low impedance (2285)

Patient Problem Syncope (1610)

Event Date 01/03/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the right ventricular (rv) lead exhibited a warning and polarity switch due to low impedance values and oversensing.The lead further exhibited no capture and the patient experienced syncopal episodes.It was noted that the oversensing was likely due to electromagnetic interference.The right ventricular (rv) lead was capped and replaced and the ipg was explanted and replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the impedance of the right ventricular pacing lead was below the expected lower range.Analysis of the device memory indicated oversensing associated with the right ventricular lead.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSURE VDD 2
• Type of Device: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8395111
• MDR Text Key: 137974906
• Report Number: 2649622-2019-03730
• Device Sequence Number: 1
• Product Code: DXY
• UDI-Device Identifier: 00885074201566
• UDI-Public: 00885074201566
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890003
• 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,Followup
• Report Date: 04/01/2019

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: 08/07/2016
• Device Model Number: 5038-58
• Device Catalogue Number: 5038-58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/06/2019
• Supplement Dates Manufacturer Received: 03/06/2019
• Supplement Dates FDA Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2014
• 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: ADDRL1 IPG
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 17 YR