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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. PACING SYSTEM ANALYZER; PROGRAMMER, PACEMAKER
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MEDTRONIC, INC. PACING SYSTEM ANALYZER; PROGRAMMER, PACEMAKER Back to Search Results
Model Number 229047
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Date 03/31/2020
Event Type  malfunction  
Manufacturer Narrative
During analysis it was identified that the analyzer failed incoming functional tests.The analyzer was replaced.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The analyzer which was returned as an associated device subsequently tested out of specification during manufacturer¿s analysis.There was no patient involvement.
 
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Brand Name
PACING SYSTEM ANALYZER
Type of Device
PROGRAMMER, PACEMAKER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10437947
MDR Text Key203887103
Report Number2182208-2020-01592
Device Sequence Number1
Product Code KRG
UDI-Device Identifier00721902256011
UDI-Public00721902256011
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P890003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number229047
Device Catalogue Number229047
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2020
Date Manufacturer Received08/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
2090 PROGRAMMER, 2067L RF HEAD
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