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

Model Number 5086MRI52

Device Problems Signal Artifact/Noise (1036); Break (1069); Fracture (1260); Low impedance (2285); Decreased Sensitivity (2534); Device-Device Incompatibility (2919); Electronic Property Issue (2928); Impedance Problem (2950)

Patient Problems Fatigue (1849); Palpitations (2467)

Event Date 04/01/2017

Event Type  Injury  

Event Description

It was reported that the patient experienced palpitations and felt tired recently.It was also reported that the right atrial (ra) lead exhibited a polarity switch to unipolar due to wide swings in impedances; including low impedance measurements.The atrial channel was noted with decreased sensing.Insulation damage was suspected.An x-ray showed the ra lead and right ventricular (rv) lead appeared to be rubbing on each other.Both leads were observed with noise and both were suspected of a fracture.Additionally, the rv lead exhibited fluctuating and low impedance reading with trend data showed dropping impedances.The rv lead was suspected of a fracture.Reprogrammed was initially performed.Both leads were later explanted and replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: a partial lead in portions was received.And analyzed.Analysis indicated that the proximal conductor of the lead developed a fracture at the first rib/clavicle location while in vivo.The outer insulation, and the inner insulation of the lead developed a breach at the first rib/clavicle location while in vivo.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSUREFIX MRI SURESCAN
• 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: 7091210
• MDR Text Key: 94089905
• Report Number: 2649622-2017-13605
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00613994657367
• UDI-Public: 00613994657367
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090013
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/03/2015
• Device Model Number: 5086MRI52
• Device Catalogue Number: 5086MRI52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2013
• 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: A2DR01 IPG, 5086MRI58 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR