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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SERENA CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W1TR02
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/01/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the right atrial (ra) lead pacing threshold had been rising for approximately one year and the pacing impedance had been increasing for more than one year. The ra lead was then checked a few months later and it was noted the pacing impedance was then high/undefined in both unipolar and bipolar configuration. The patient was referred for a lead replacement and a ra lead fracture was suspected. During the revision procedure, the physician capped the ra lead and replaced with a new lead. While attempting to connect the new ra lead to the cardiac resynchronization therapy pacemaker (crt-p), the physician could no longer get the wrench to engage the setscrew of the device. The physician noted the wrench seemed to go through the grommet as expected, however, the wrench would not seat on the setscrew. The wrench was tried on the ventricular lead and no anomalies were observed. A second wrench was used to engage the atrial setscrew to no avail. The physician elected to replace the crt-p, as they did not believe there was an issue with wrench. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the device was returned and analyzed. Returned product analysis was performed and no anomalies were found. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSERENA 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 Key9842883
MDR Text Key183749269
Report Number3004209178-2020-05541
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00643169735651
UDI-Public00643169735651
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 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2020
Device Model NumberW1TR02
Device Catalogue NumberW1TR02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2019
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: 03/17/2020 Patient Sequence Number: 1
Treatment
5076-58 LEAD, 5076-52 LEAD, 419378 LEAD
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