MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SERENA CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

Model Number W1TR02

Device Problem Pacing Problem (1439)

Patient Problem Dizziness (2194)

Event Date 01/18/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 383069, lead, implanted: (b)(6) 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced dizziness.It was also reported that during use of the cardiac resynchronization therapy pacemaker (crt-p), the patient is having pause events up to four seconds in duration with no pacer spikes visible during those events.The crt-p remains in use.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

Additional information received indicated rv capture management and lv capture management were programmed off.No patient complications have been reported as a result of this event.

• Brand Name: SERENA CRT-P MRI SURESCAN
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9681879
• MDR Text Key: 178216365
• Report Number: 3004209178-2020-02816
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169735651
• UDI-Public: 00643169735651
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2021
• Device Model Number: W1TR02
• Device Catalogue Number: W1TR02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2020
• Date Device Manufactured: 11/11/2019
• 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: 5076-45 LEAD, 5076-52 LEAD
• Patient Age: 77 YR