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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SOLARA QUAD CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number W4TR03
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stroke/CVA (1770)
Event Date 10/02/2019
Event Type  Injury  
Event Description
It was reported that the patient experienced a stroke post implant and during normal follow up. The patient was treated and recovered per the physician. The device and lead remain in use. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Concomitant medical products: 429878 lead implanted (b)(6) 2019. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSOLARA QUAD CRT-P MRI SURESCAN
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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 Key12770837
MDR Text Key280462478
Report Number3004209178-2021-16582
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00643169735682
UDI-Public00643169735682
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,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/28/2021
Device Model NumberW4TR03
Device Catalogue NumberW4TR03
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/11/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/29/2019
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: 11/08/2021 Patient Sequence Number: 1
Treatment
5076-52 LEAD, 5076-58 LEAD
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