MAUDE Adverse Event Report: MPRI ATTAIN STARFIX LEAD; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P

Model Number 419588

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Erythema (1840); Fistula (1862); Unspecified Infection (1930); Impaired Healing (2378); Fluid Discharge (2686)

Event Date 07/07/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 407652 lead, implanted: (b)(6) 2014; dtma1d1 crt-d, implanted: (b)(6) 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced an infection of unknown etiology.The cardiac resynchronization therapy defibrillator (crt-d) and leads were explanted and not replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The referenced previous fistula tract is captured for this lead in regulatory report #2649622-2022-01186 section c: c1:drug name: beclomethasone dipropionate c1: approval number: unk c1: drug lot number: b09015069v c3: route: intracardiac c4: treatment/therapy from date: (b)(6) 2014, c4: treatment/therapy to date: (b)(6) 2021, c5: diagnosis use for: suppression of inflammatory response.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.

Event Description

Additional information indicated that approximately six weeks prior to the infection and subsequent explant of the crt-d system, the patient experienced reddened/elevated bump over superior aspect of device site and pocket with thinning skin noted over area.Diagnostic examination revealed that pocket dehiscence was noted.It was also noted that when the device was in a previous location a fistula tract had developed and it appeared to be occurring again in the new location.The pocket was irrigated, the device was moved laterally, a new antibacterial envelope was implanted and the patient was treated with antibiotics.The patient is a participant in a clinical study.

Event Description

It was further reported that when the patient presented with the infection drainage was noted from the device site and the pocket was not healing and the patient was treated with antibiotics again.

Manufacturer Narrative

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 STARFIX LEAD
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
• 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 Key: 12367352
• MDR Text Key: 268131557
• Report Number: 2649622-2021-17330
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00885074511955
• UDI-Public: 00885074511955
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/22/2010
• Device Model Number: 419588
• Device Catalogue Number: 419588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2022
• Date Device Manufactured: 09/10/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 693565 LEAD; TYRX-AAE ENVELOPE; 693565 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Race: White