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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. ANALYZER CABLE PROGRAMMER, PACEMAKER

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MEDTRONIC, INC. ANALYZER CABLE PROGRAMMER, PACEMAKER Back to Search Results
Model Number 2292
Device Problem Failure to Capture (1081)
Patient Problems Arrhythmia (1721); Seizures (2063)
Event Date 05/23/2018
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

It was reported that during a device change procedure, a patient with complete heart block and no underlying escape rhythm, was disconnected from the old device and connected to the lead analyzer cables, which were connected to a programmer. Pacing spikes were evident on surface electrocardiogram (ecg), however, there were no signs of capture to follow. The lead and programmer connections were checked and were fine, however there was no change, even with very high outputs. It was noted that the patient had ventricular standstill and early signs of seizure. The new device was implanted without issue, and the cables were recommended to be returned for analysis, but the current status is unknown. No further patient complications have been reported as a result of this event.

 
Manufacturer Narrative

Product analysis: analysis could not confirm the customer comment, the cable passed all visual inspection with no anomalies found. All continuity tests were ok. And no intermittent or shorted connections were found. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was further reported that the cables were returned to service.

 
Manufacturer Narrative

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

 
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Brand NameANALYZER CABLE
Type of DevicePROGRAMMER, 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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7601199
MDR Text Key111050517
Report Number2182208-2018-01113
Device Sequence Number1
Product Code KRG
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberP890003
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 10/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/14/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2292
Device Catalogue Number2292
Device LOT NumberID1800054
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/27/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
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: 06/14/2018 Patient Sequence Number: 1
Treatment
2090 PROGRAMMER, 229047 ANALYZER
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