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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 08/21/2020
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 patient had experienced severe pain at the site of the cardiac resynchronization therapy pacemaker (crt-p) implant. It was noted that the skin adjacent to the incision and overlaying the crt-p was very sensitive, slightly blanched, and any movement or touching caused significant shooting pain. The patient stated that the crt-p was too close to the surface of the skin. A pocket revision was done and the crt-p remains in use. The patient is a participant in a clinical study. No further patient complications have been reported as a result of this event.
 
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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 Key10830584
MDR Text Key215958075
Report Number3004209178-2020-19885
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,study
Reporter Occupation
Type of Report Initial
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/14/2021
Device Model NumberW1TR02
Device Catalogue NumberW1TR02
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 Received10/19/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/14/2020
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: 11/12/2020 Patient Sequence Number: 1
Treatment
383059 LEAD, 383069 LEAD, 5076-58 LEAD
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