MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. CLARIA MRI CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTMA1D1

Device Problems Premature Discharge of Battery (1057); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) exhibited premature battery depletion and reached end of life (eol), so the patient was not received any pacing support.It was noted that the device would not connect with any programmers, despite multiple configurations being used.The crt-d was explanted and replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.The returned device indicated shorting/low impedance in the battery.Hybrid analysis revealed that the device loss of telemetry and all functions were due to a severely depleted battery.The device was fully functional and operated under normal current drain when powered with an external supply.There was no evidence of a high current drain condition, and no hybrid anomalies were observed.Battery analysis revealed that plated lithium was found to initiate from the case, extend under the head space insulator (hsi), and contact the cathode tab.Based on this, the premature battery depletion after was determined to be the result of a plated lithium short between the battery case (negative polarity) and the cathode tab (positive polarity.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.

• Brand Name: CLARIA MRI 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 Key: 12168074
• MDR Text Key: 261556214
• Report Number: 3004209178-2021-10837
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169705777
• UDI-Public: 00643169705777
• Combination Product (y/n): N
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

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 Date: 04/28/2018
• Device Model Number: DTMA1D1
• Device Catalogue Number: DTMA1D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 09/17/2021
• Supplement Dates FDA Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 429688 LEAD, 407652 LEAD, 693565 LEAD; 429688 LEAD, 407652 LEAD, 693565 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 107