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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SERENA QUAD CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W4TR02
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the implant of a cardiac resynchronization therapy pacemaker (crt-p) the setscrew was unable to be engaged. The crt-p was removed and replaced. No patient complications have been reported as a result of this event.
 
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Brand NameSERENA QUAD CRT-P MRI SURESCAN
Type of DevicePULSE 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 Key8796593
MDR Text Key151282064
Report Number3004209178-2019-13657
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00643169735668
UDI-Public00643169735668
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2019
Device Model NumberW4TR02
Device Catalogue NumberW4TR02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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