MAUDE Adverse Event Report: MPRI CAPSUREFIX; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number 4068-52

Device Problems Low impedance (2285); Electronic Property Issue (2928)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: 4068-45 lead, implanted: (b)(6) 2000.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 low impedance and a polarity switch.The lead was capped and replaced.The patient is a participant in the product surveillance registry study.No patient complications have been reported as a result of this event.

• Brand Name: CAPSUREFIX
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• 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: 7277409
• MDR Text Key: 100303926
• Report Number: 2649622-2018-02654
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930039
• 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: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/07/2001
• Device Model Number: 4068-52
• Device Catalogue Number: 4068-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2016
• 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: ADDR01 IPG
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR