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U.S. Department of Health and Human Services

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

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MEDTRONIC EUROPE SARL SERENA QUAD CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
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.
 
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Brand NameSERENA QUAD CRT-P MRI SURESCAN
Type of DevicePULSE 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 Key11819021
MDR Text Key250429358
Report Number9614453-2021-01990
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
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 Received05/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2019
Device Model NumberW4TR02
Device Catalogue NumberW4TR02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/30/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/13/2021 Patient Sequence Number: 1
Treatment
429888 LEAD
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