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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI SPRINT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

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MPRI SPRINT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number 6943
Device Problem High impedance (1291)
Patient Problem Obstruction/Occlusion (2422)
Event Date 09/16/2022
Event Type  Injury  
Event Description
It was reported that the epicardial right ventricular (rv) lead exhibited high/undefined rv coil impedance.A laser was used to remove the lead, however when tension was put on the lead with a locking stylet in the lumen, the proximal part of the lead was only removed.The laser could only go a few centimeters into the subclavian vein with a noticeable occlusion near the superior vena cava (svc) junction.A venogram was performed and there was no access from the left side due to the occlusion.The rv and svc ports were plugged and the icd is being used as a pacemaker only. no further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Continuation of d10: 411863 competitor lead implanted: 25feb2004; 428222 competitor lead implanted: (b)(6).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
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 right ventricular defibrillation coil was beyond the expected upper range.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
SPRINT
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer (Section G)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key16752461
MDR Text Key313420535
Report Number2649622-2023-09538
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P920015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/15/2023
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 Date01/09/2006
Device Model Number6943
Device Catalogue Number6943
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/12/2023
Initial Date FDA Received04/17/2023
Supplement Dates Manufacturer Received04/18/2023
Supplement Dates FDA Received05/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2004
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
DDBB2D1 ICD
Patient Outcome(s) Required Intervention; Hospitalization;
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