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

Model Number	C4TR01
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Dyspnea (1816); Shaking/Tremors (2515)
Date of Event	05/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was experiencing shortness of breath and was shaking.It was further reported that an electrocardiogram (ekg) showed that the cardiac resynchronization therapy pacemaker (crt-p) was failing.The crt-p remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Concomitant medical products: 429688 lead, implanted: (b)(6) 2014.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONSULTA CRT-P
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 14453431
• Report Number: 9614453-2022-01463
• Device Sequence Number: 12366733
• Product Code: NVZ
• UDI-Device Identifier: 00613994713667
• UDI-Public: 00613994713667
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P010015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/28/2015
• Device Model Number: C4TR01
• Device Catalogue Number: C4TR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2022
• Initial Report FDA Received Date: 05/20/2022
• Date Device Manufactured: 04/01/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5068-58 LEAD, 4068-52 LEAD.
• Patient Sex: Male
• Patient Weight: 53 KG