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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. CLARIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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MEDTRONIC PUERTO RICO OPERATIONS CO. CLARIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number DTMA1QQ
Device Problems Premature Discharge of Battery (1057); Failure to Charge (1085); Electrical /Electronic Property Problem (1198); Delayed Charge Time (2586)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that there was an alert for a charge circuit timeout, charge circuit inactive, and a longer than expected charge time.The device was noted to have triggered end of service (eos) prematurely and was explanted and replaced.It was also noted the right ventricular (rv) lead threshold allegedly went up and an alert for high rv threshold occurred.The lead was explanted and replaced.No patient complications have been reported as a result of this event.
 
Event Description
It was reported that there was an alert for a charge circuit timeout, charge circuit inactive, and a longer than expected charge time.The device was noted to have triggered end of service (eos) prematurely and was explanted and replaced.It was also noted the right ventricular (rv) lead threshold allegedly went up and an alert for high rv threshold occurred.During the revision procedure, the rv lead was attempted to be moved, however, the helix would not retract and deploy properly.The physician was unsure if the helix was out or going back in properly, therefore, the rv lead was explanted and replaced.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Correction: b5 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 device was returned and analyzed.The returned device indicated current leakage in the integrated circuit due to gate/cap oxide breakdown.Device analysis revealed that the device memory also had recorded 2 charge timeouts while implanted on (b)(6) 2021 while still implanted.Both loaded and unloaded pacing current drain levels were high out of specifications.The device also had a high out of specification rv defib lead impedance measurement.It was verified that the device was unable to properly charge the hv capacitors.No visual hybrid anomalies were observed.Hybrid analysis revealed that the high current was isolated to a faulty l303 ic(integrated circuit).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
CLARIA MRI QUAD CRT-D SURESCAN
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key11321980
MDR Text Key231614885
Report Number3004209178-2021-02506
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00643169720633
UDI-Public00643169720633
Combination Product (y/n)N
PMA/PMN Number
P010031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 04/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/14/2021
Device Model NumberDTMA1QQ
Device Catalogue NumberDTMA1QQ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2021
Date Manufacturer Received03/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
439888 LEAD, 6935M62 LEAD, 5076-52 LEAD; 439888 LEAD, 6935M62 LEAD, 5076-52 LEAD
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age47 YR
Patient Weight142
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