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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICE CREEK MFG MEDTRONIC CABLE; PULSE-GENERATOR, PACEMAKER, EXTERNAL

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RICE CREEK MFG MEDTRONIC CABLE; PULSE-GENERATOR, PACEMAKER, EXTERNAL Back to Search Results
Model Number MDT-CABLE
Device Problem Material Integrity Problem (2978)
Patient Problems Arrhythmia (1721); Bradycardia (1751)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that external pulse generators (epgs) were directly related to patients experiencing bradycardia and fibrillation.It was further reported that these events were related to the device (epg) settings, epg connection issues and external epg cabling issues.The current status of the epgs is unknown.It was indicated that the events led to permanent injury.There is no additional information available.
 
Manufacturer Narrative
Concomitant medical products: product id: 5392.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that external pulse generators (epgs) were directly related to patients experiencing bradycardia and fibrillation.It was further reported that these events were related to the device (epg) settings, epg connection issues and external epg cablingissues.The current status of the epgs is unknown.It was indicated that the events led to permanent injury.There is no additional information available.
 
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Brand Name
MEDTRONIC CABLE
Type of Device
PULSE-GENERATOR, PACEMAKER, EXTERNAL
Manufacturer (Section D)
RICE CREEK MFG
7000 central ave ne
fridley MN 55432
MDR Report Key8746637
MDR Text Key149626972
Report Number6000030-2019-00063
Device Sequence Number1
Product Code DTE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 06/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMDT-CABLE
Device Catalogue NumberMDT-CABLE
Was Device Available for Evaluation? No
Date Manufacturer Received05/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
5392
Patient Outcome(s) Life Threatening;
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