MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE S MRI SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number 6935M62

Device Problems Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439); Device Dislodged or Dislocated (2923)

Patient Problems Dyspnea (1816); Fatigue (1849); Weakness (2145); Complaint, Ill-Defined (2331)

Event Date 02/21/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 429888 lead; implanted: (b)(6) 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that post a left ventricular lead revision procedure, the right ventricular (rv) lead dislodged and was sensing both the atrium and ventricle.The lead had no capture in the ventricle but was capturing the atrium at high outputs and the patient was symptomatic with the dysfunctional pacing.The lead was explanted and replaced.No further 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 further reported that the patient experienced shortness of breath, weakness and lack of energy.

Manufacturer Narrative

Product event 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 cross chamber oversensing associated with the right ventricular lead.Analysis of the device memory indicated oversensing due to non-physiologic signals/sensing integrity counter.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPRINT QUATTRO SECURE S MRI SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9860146
• MDR Text Key: 184287491
• Report Number: 2649622-2020-05741
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00643169356566
• UDI-Public: 00643169356566
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P920015
• 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,Followup
• Report Date: 03/24/2020

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: 02/14/2021
• Device Model Number: 6935M62
• Device Catalogue Number: 6935M62
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 03/20/2020; 03/23/2020
• Supplement Dates FDA Received: 03/23/2020; 03/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• 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: 5076-52 LEAD, DTMB1QQ CRT-D
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 89 YR