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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W1TR01
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant products: 383069, lead, implanted (b)(6) 2020. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the cardiac resynchronization therapy pacemaker (crt-p) displayed invalid trending data. The device remains in use. No patient complications have been reported as a result of this event.
 
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Brand NamePERCEPTA 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 Key11515632
MDR Text Key240646248
Report Number3004209178-2021-04490
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 company representative
Reporter Occupation
Type of Report Initial
Report Date 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2021
Device Model NumberW1TR01
Device Catalogue NumberW1TR01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/04/2019
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: 03/18/2021 Patient Sequence Number: 1
Treatment
5076-45 LEAD, 5076-52 LEAD
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