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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND RING, ANNULOPLASTY

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MEDTRONIC HEART VALVES DIVISION SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND RING, ANNULOPLASTY Back to Search Results
Model Number 700FC31
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Complete Heart Block (2627)
Event Date 02/17/2020
Event Type  Injury  
Manufacturer Narrative

Product analysis: the device remains implanted; therefore, no product analysis can be performed. Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation. Conduction disturbances are known potential adverse effects associated with any cardiac or thoracic procedure and can be resolved with medical treatment or the implant of a permanent pacemaker. A conduction disturbance does not indicate a device malfunction or potential manufacturing issue. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received information that 6 days post implant of a 31 mm annuloplasty mitral band, a permanent pacemaker was implanted. The reason for permanent pacemaker implant was reported as 3rd degree complete heart block. No additional adverse patient effects were reported.  .

 
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Brand NameSIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND
Type of DeviceRING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer (Section G)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key10327163
MDR Text Key200446896
Report Number2025587-2020-02352
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK052899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 07/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number700FC31
Device Catalogue Number700FC31
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 Received07/18/2020
Was Device Evaluated By Manufacturer? No Answer Provided
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: 07/27/2020 Patient Sequence Number: 1
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