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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 Unspecified Infection (1930)
Event Date 06/28/2022
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 6725 adaptor implanted (b)(6) 2017. Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿. These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting. Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that cardiac resynchronization therapy pacemaker (crt-p) system was extracted due to an infection post chemotherapy. A temporary pacing lead was placed and the crt-p was used until a new crt-p system was implanted 8 days later. No further patient complications have been reported as a result of this event.
 
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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 Key15074037
MDR Text Key296297286
Report Number3004209178-2022-09277
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,Followup
Report Date 08/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/14/2018
Device Model NumberW4TR03
Device Catalogue NumberW4TR03
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2017
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: 07/21/2022 Patient Sequence Number: 1
Treatment
429878 LEAD, 5076-52 LEAD
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