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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MILACA, INC. DUAL CHAMBER TEMPORARY PACEMAKER; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

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MEDTRONIC MILACA, INC. DUAL CHAMBER TEMPORARY PACEMAKER; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number 5388XG
Device Problems Use of Device Problem (1670); Calibration Problem (2890); Inadequate User Interface (2958)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/21/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the menu of the external pulse generator (epg) could not be accessed.The epg is expected to return for service.There was no patient involvement.
 
Manufacturer Narrative
Product analysis: analysis was able to confirm the customer comment that the menu of the external pulse generator (epg) could not be accessed.It was noted that no information or settings were visible on the lower liquid crystal display (lcd) and that the the lcd and main printed circuit board (pcb) were defective.Contamination was observed on the battery chamber, release mechanism and associated parts.The epg was not repaired as it was no longer serviceable.The epg was shipped back to the customer unrepaired.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 further reported that the epg was returned for service.
 
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Brand Name
DUAL CHAMBER TEMPORARY PACEMAKER
Type of Device
IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
Manufacturer (Section D)
MEDTRONIC MILACA, INC.
900 sixth avenue ne
milaca MN 56353 3728
MDR Report Key11271732
MDR Text Key230023822
Report Number2183613-2021-00019
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
PMA/PMN Number
P820003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 08/18/2021
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 Health Professional
Device Model Number5388XG
Device Catalogue Number5388XG
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2021
Initial Date Manufacturer Received 01/21/2021
Initial Date FDA Received02/03/2021
Supplement Dates Manufacturer Received08/02/2021
Supplement Dates FDA Received08/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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