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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA

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MEDTRONIC PUERTO RICO OPERATIONS CO. REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number 9529
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/24/2016
Event Type  Malfunction  
Event Description

It was reported that prior to implant it was discovered that the device packaging was not sealed properly. The device was not implanted. No patient complications have been reported as a result of this event.

 
Manufacturer Narrative

Product event summary - the device was returned and analyzed and no anomalies were found.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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Brand NameREVEAL XT
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key5863155
MDR Text Key51823033
Report Number3004209178-2016-16419
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK103764
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 05/24/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/09/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/14/2016
Device MODEL Number9529
Device Catalogue Number9529
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/09/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/16/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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