MAUDE Adverse Event Report: MPRI ATTAIN ABILITY STRAIGHT MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number	439688
Medical Device Problem Codes	Failure to Capture (1081); Capturing Problem (2891); Adverse Event Without Identified Device or Use Problem (2993); High Capture Threshold (3266)
Health Effect - Clinical Codes	Muscle Stimulation (1412); Cardiomyopathy (1764); Dyspnea (1816); Edema (1820); Unspecified Infection (1930); Pulmonary Edema (2020); Swelling (2091); Heart Failure (2206)
Date of Event	05/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was experiencing diaphragmatic stimulation.The left ventricular (lv) lead was explanted and replaced.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information reported the patient was experiencing worsening heart failure, cardiomyopathy, swelling, edema, shortness of breath, was being treated for a respiratory infection suspected to be related to fluid accumulation, and a chest x-ray noted pulmonary edema.The patient was treated with an increase in oral diuretics.It was further reported that the diaphragmatic stimulation was positional and reprogramming was performed prior to explant.The lv lead also exhibited loss of capture, a rise in thresholds, and high thresholds.The patient is a participant in the post approval clinical surveillance product surveillance registry.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the full lead was returned, analyzed, and no anomalies were found.Visual analysis of the lead indicated apparent explant damage.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product event summary: the proximal portion of the lead was returned, analyzed, and no anomalies were found.Visual analysis of the lead indicated apparent explant damage.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received indicated the lv lead was capped, and placement of two new competitor epicardial lv leads was performed.Approximately sixteen months later, during a competitor leads revision procedure, at the site of the capped lv lead, an old full infection was noted.Given the signs of full infection, antibiotic medication was administered.The pocket was irrigated with saline solution, and the cap cleaned and replaced.
Additional Manufacturer Narrative
Correction: b5.Desc evt problem.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: ATTAIN ABILITY STRAIGHT MRI SURESCAN
• Common Device Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8761236
• Report Number: 2649622-2019-11547
• Device Sequence Number: 19165102
• Product Code: OJX
• UDI-Device Identifier: 00643169601819
• UDI-Public: 00643169601819
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/07/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/07/2018
• Device Model Number: 439688
• Device Catalogue Number: 439688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 07/08/2019; 11/07/2019; 12/03/2019; 02/03/2020; 10/07/2020
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 07/12/2019; 12/03/2019; 12/23/2019; 02/06/2020; 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: C4TR01 CRTP, 5076-58 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 114