MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PERCEPTA CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

Model Number W1TR01

Device Problems Signal Artifact/Noise (1036); Misconnection (1399); Over-Sensing (1438)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that noise was observed on the attempted right ventricular (rv) lead when connected to the attempted cardiac resynchronization therapy pacemaker (crt-p).The physician noted that when the lead was placed in the device header, it did not feel correct.The lead was removed and a new lead was placed; however, the noise continued.The crt-p was then replaced and the oversensing resolved.The physician determined that the attempted crt-p had caused the oversensing.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: PERCEPTA CRT-P MRI SURESCAN
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• MDR Report Key: 10337356
• MDR Text Key: 200767573
• Report Number: 9614453-2020-02330
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169891401
• UDI-Public: 00643169891401
• Combination Product (y/n): N
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2021
• Device Model Number: W1TR01
• Device Catalogue Number: W1TR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR