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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 Name
SOLARA QUAD CRT-P MRI SURESCAN
Type of Device
PULSE 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 Physician
Type of Report Initial
Report Date 11/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/28/2021
Device Model NumberW4TR03
Device Catalogue NumberW4TR03
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/11/2021
Initial Date FDA Received11/08/2021
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 Sequence Number1
Treatment
5076-52 LEAD, 5076-58 LEAD
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age62 YR
Patient SexMale
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