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

Model Number 4068-52

Device Problems Electronic Property Issue (2928); Impedance Problem (2950)

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

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 4568 lead, implanted (b)(6) 2000.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that subsequent to a routine device replacement procedure, the right atrial and right ventricular lead pacing impedances were measuring lower and a polarity switch was triggered.It was determined that the new device calculated impedance differently than the old device, but an insulation issue with the leads was also being evaluated through non-invasive testing.The leads' threshold and sensing were as expected with the new device and the physician stated not wanting to revise the leads due to the patient's age.The leads 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.

Event Description

It was later reported that insulation was not felt to be an issue.The impedances will be monitored by the device clinic and no intervention was done.

• 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: 7654859
• MDR Text Key: 112876204
• Report Number: 2649622-2018-10729
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/18/2002
• Device Model Number: 4068-52
• Device Catalogue Number: 4068-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/02/2018
• 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: W1DR01 IPG
• Patient Age: 93 YR