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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ATTAIN BIPOLAR OVER THE WIRE LEAD; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
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MPRI ATTAIN BIPOLAR OVER THE WIRE LEAD; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE Back to Search Results
Model Number 419478
Device Problem High Capture Threshold (3266)
Patient Problem Occlusion (1984)
Event Date 05/19/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: w1tr03 crt-p, implanted (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient was brought in for an extraction of the cardiac resynchronization therapy pacemaker (crt-p) system.The subclavian vein appeared to be sub-totally occluded and could not be traversed.Multiple lead to lead adhesions were also noted.The right atrial (ra) lead was explanted and replaced.The right ventricular (rv) lead was reported to have an outer conductor fracture with high pacing impedance and pacing thresholds.The lead was transected as the helix could not be retracted.The lead was explanted and replaced.The left ventricular (lv) lead exhibited high pacing thresholds.The lead was explanted and replaced.It was also reported that the crt-p exhibited premature battery depletion due to the fracture and high pacing thresholds.The device was explanted and replaced.No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the distal portion of the 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.
 
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Brand Name
ATTAIN BIPOLAR OVER THE WIRE LEAD
Type of Device
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key10118156
MDR Text Key193927749
Report Number2649622-2020-10584
Device Sequence Number1
Product Code LWP
UDI-Device Identifier00885074113364
UDI-Public00885074113364
Combination Product (y/n)N
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/19/2020
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 Date01/27/2012
Device Model Number419478
Device Catalogue Number419478
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2020
Initial Date Manufacturer Received 05/19/2020
Initial Date FDA Received06/04/2020
Supplement Dates Manufacturer Received06/10/2020
Supplement Dates FDA Received06/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
5076-52 LEAD, 5076-45 LEAD; 5076-52 LEAD, 5076-45 LEAD
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age59 YR
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