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

Model Number W4TR02

Device Problems Failure to Interrogate (1332); Pacing Problem (1439)

Patient Problems Bradycardia (1751); Fall (1848); Hematoma (1884)

Event Date 04/15/2021

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: 5076-58 lead, implanted: (b)(6) 2008; 5524m45 lead, implanted: (b)(6) 1998.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented after having fallen at home.The patient's heart rate was reported to have dropped to the thirty beats per minute range.It was noted that the cardiac resynchronization therapy pacemaker's (crt-p) programmed lower rate was sixty beats per minute.An attempt was made to interrogate the crt-p but the device could not be detected.The patient was transferred to a different facility where the device was successfully interrogated and device function appeared normal.The patient's hospital admission diagnosis was subdural hematoma.The patient was noted to have expired less than two weeks later.Additional information related to the cause of death was requested and is not available.

• Brand Name: SERENA QUAD 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 ; 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: 11819021
• MDR Text Key: 250429358
• Report Number: 9614453-2021-01990
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169891432
• UDI-Public: 00643169891432
• 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
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2019
• Device Model Number: W4TR02
• Device Catalogue Number: W4TR02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2021
• Date Device Manufactured: 10/30/2017
• 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: 429888 LEAD
• Patient Outcome(s): Death
• Patient Age: 85 YR
• Patient Weight: 74