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

Model Number 5038-58

Device Problems Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Over-Sensing (1438); Connection Problem (2900)

Patient Problem Syncope (1610)

Event Date 09/19/2016

Event Type  Injury  

Manufacturer Narrative

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 on the rv (right ventricular) pacing lead was beyond the expected upper range.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient went to the hospital due to syncope.The physician detected high impedance values and one episode of very high frequency (that is suspected to be noise) and a little increase of the threshold.The physician suspects that it could be a lead fracture, or a bad connection between the lead and the device.The device and lead were subsequently explanted and replaced.No further patient complications have been reported as a result of this event.

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6163468
• MDR Text Key: 62099877
• Report Number: 2649622-2016-15731
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2016

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: 11/09/2017
• 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: 09/21/2016
• Initial Date FDA Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2015
• 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: ADVDD01 IPG
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention