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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ATTAIN PERFORMA STRAIGHT MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

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MPRI ATTAIN PERFORMA STRAIGHT MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 439888
Device Problems Signal Artifact/Noise (1036); Intermittent Capture (1080); High impedance (1291); Low impedance (2285); Impedance Problem (2950)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2020
Event Type  Injury  
Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the impedance of the left ventricular pacing lead was below the expected lower range.Analysis of the device memory indicated the impedance trend of the left ventricular pacing lead was variable.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that there was an alert for low impedance on the left ventricular (lv) lead.Impedance variations and noise on were also noted on electrogram.The lv lead remains in use.No patient complications have been reported as a result of this event.
 
Event Description
It was later reported that the lead was programmed off.
 
Manufacturer Narrative
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 there was intermittent capture and high impedance on the lv lead.The lead was explanted and replaced.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
Correction: b7.Product event summary: the full lead was returned, analyzed and no anomalies were found.Visual analysis of the lead indicated apparent explant damage.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.
 
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Brand Name
ATTAIN PERFORMA STRAIGHT MRI SURESCAN
Type of Device
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key10566798
MDR Text Key207921993
Report Number2649622-2020-18147
Device Sequence Number1
Product Code OJX
UDI-Device Identifier00643169601857
UDI-Public00643169601857
Combination Product (y/n)N
PMA/PMN Number
P080006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 05/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/12/2021
Device Model Number439888
Device Catalogue Number439888
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2021
Initial Date Manufacturer Received 08/31/2020
Initial Date FDA Received09/22/2020
Supplement Dates Manufacturer Received03/11/2021
04/13/2021
05/19/2021
Supplement Dates FDA Received03/26/2021
05/07/2021
05/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
407652 LEAD, 6935M62 LEAD, DTMB1QQ CRTD; 407652 LEAD, 6935M62 LEAD, DTMB1QQ CRTD
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age58 YR
Patient Weight125
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