MAUDE Adverse Event Report: ABBOTT MEDICAL KIT TRIAL SLIM TIP LEAD, 90CM; DRG TRIAL SLIM TIP LEAD

Model Number	MN10350-90A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	08/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
Event or Problem Description
Related manufacturer reference number: 1627487-2021-17036.It was reported the patient had a trial procedure on (b)(6) 2021 and during the trial period the patient had a heart attack on (b)(6) 2021.The patient turned the stimulation off on the afternoon of (b)(6) 2021.Surgical intervention took place wherein the trial leads were removed.Patient is stable.

• Brand Name: KIT TRIAL SLIM TIP LEAD, 90CM
• Common Device Name: DRG TRIAL SLIM TIP LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12478110
• Report Number: 1627487-2021-17038
• Device Sequence Number: 17072261
• Product Code: PMP
• UDI-Device Identifier: 05415067027146
• UDI-Public: 05415067027146
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2022
• Device Model Number: MN10350-90A
• Device Catalogue Number: MN10350-90A
• Device Lot Number: 7487040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2021
• Initial Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 84