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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. CARELINK; PROGRAMMER, PACEMAKER

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MEDTRONIC, INC. CARELINK; PROGRAMMER, PACEMAKER Back to Search Results
Model Number 2090
Device Problems Crack (1135); Noise, Audible (3273)
Patient Problem No Patient Involvement (2645)
Event Date 03/19/2015
Event Type  malfunction  
Manufacturer Narrative
This report is based solely on device analysis.No information to suggest a device related adverse event or product problem was received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: analysis confirmed the customer comment that the overlay was cracked, power cord bay door broken, one hinge plate screw missing and system fan was noisy.Analysis also found that the electrocardiogram connector was loose and therefore the link electronic module printed circuit board was replaced and calibrated.All found defective parts were replaced.Product id: 229047 software analyzer.(b)(4).
 
Event Description
It was reported that the programmer screen was cracked, the power cord lid was broken, a screw came out of the bottom of the programmer and the fan was loud.The programmer was returned for repair.No patient complications have been reported as a result of this event.It was further reported that the programmer subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.
 
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Brand Name
CARELINK
Type of Device
PROGRAMMER, PACEMAKER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC CARDIAC RHYTHM HEART FAILURE
8200 coral sea st ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key4971813
MDR Text Key23675605
Report Number2182208-2015-02937
Device Sequence Number1
Product Code KRG
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 Other
Report Date 05/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2090
Device Catalogue Number2090
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/05/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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