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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE S MRI SURESCAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

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MPRI SPRINT QUATTRO SECURE S MRI SURESCAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number 6935M55
Device Problems Failure to Capture (1081); Over-Sensing (1438); Under-Sensing (1661)
Patient Problem Cardiac Arrest (1762)
Event Date 02/28/2024
Event Type  Death  
Event Description
It was reported that the patient went into cardiac arrest and had a long bout of cardiopulmonary resuscitation, however, the patient passed.The patient¿s spouse heard the device tone and thought that the patient may have received a shock however, no shock was delivered.It was further noted that on the date prior to the patient passing, the stored ventricular tachycardia non-sustained (vt-ns) and high rate non-sustained (hr-ns) electrograms (egm) appeared to be potential agonal type rhythm and the right ventricular (rv) lead triggered a lead integrity alert (lia).It was also reported that there was oversensing and undersensing at times during vt-ns and hr-ns episodes with no capture on the right atrial (ra) lead and rv lead on stored and current egms.Lastly, it was noted that there was possible high thresholds on the left ventricular (lv) lead.
 
Manufacturer Narrative
Continuation of d10: 5076-45, lead, implanted (b)(6) 2017.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
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Brand Name
SPRINT QUATTRO SECURE S MRI SURESCAN
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 Key18951423
MDR Text Key338260900
Report Number2649622-2024-07800
Device Sequence Number1
Product Code LWS
UDI-Device Identifier00643169356559
UDI-Public00643169356559
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P920015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/21/2024
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 Date05/26/2019
Device Model Number6935M55
Device Catalogue Number6935M55
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/28/2024
Initial Date FDA Received03/21/2024
Date Device Manufactured06/12/2017
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
DTPB2QQ CRT-D, 429888 LEAD
Patient Outcome(s) Death;
Patient Age72 YR
Patient SexMale
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