MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL CONSULTA CRT-P; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number C4TR01

Device Problems Unable to Obtain Readings (1516); Failure to Transmit Record (1521)

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

Event Date 04/01/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 429688 lead, implanted: (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient's cardiac resynchronization therapy pacemaker (crt-p) stopped recording intrathoracic impedance measurements.No intervention was taken and the crt-p remains 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.

• Brand Name: CONSULTA CRT-P
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7669852
• MDR Text Key: 113790226
• Report Number: 9614453-2018-02510
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00613994713667
• UDI-Public: 00613994713667
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010015
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2016
• Device Model Number: C4TR01
• Device Catalogue Number: C4TR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 09/13/2014
• 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
• Patient Age: 82 YR
• Patient Weight: 104