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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. ANALYZER, PACEMAKER GENERATOR FUNCTION

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MEDTRONIC, INC. ANALYZER, PACEMAKER GENERATOR FUNCTION Back to Search Results
Model Number 5311B
Device Problem Output Problem (3005)
Patient Problem Cardiac Arrest (1762)
Event Date 02/02/2014
Event Type  Injury  
Event Description

It was reported that while the analyzer was being used with a temporary pacing lead on a patient, it was noted that the pulse rate of the patient had decreased to lower than 10 bpm on the electrocardiogram monitor, and the patient became unwell. The initial settings are unknown. The same day a permanent implantable pulse generator (ipg) was implanted. Since this model is no longer maintained by the manufacturer, it was recommended to not use this device in the future. The device remains at the hospital. No further patient complications were reported as a result of this event.

 
Manufacturer Narrative

This event occurred outside the us where the same model is distributed. All information provided is included in this report. Patient information is not generally available due to confidentiality concerns. (b)(4).

 
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Type of DeviceANALYZER, PACEMAKER GENERATOR FUNCTION
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC CARDIAC RHYTHM DISEASE MGMT
8200 coral sea st ne
mounds view MN 55112
Manufacturer Contact
nashoane fulwood-kelley
8200 coral sea st ne
mounds view, MN 55112
7635260583
MDR Report Key3743014
MDR Text Key4414898
Report Number2182208-2014-01006
Device Sequence Number1
Product Code DTC
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK884331
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/03/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/11/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5311B
Device Catalogue Number5311B
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/03/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 04/11/2014 Patient Sequence Number: 1
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