MAUDE Adverse Event Report: MEDTRONIC, INC. 3.2 MM BI LEAD TO IS-1 BI IPG - PERMANENT EXTENSION, ADAPTOR KIT; ADAPTOR, LEAD, PACEMAKER

Model Number	5866-40M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: d224vrc, implanted: (b)(6) 2010; 6966110, implanted: (b)(6) 1994; 6961, implanted: (b)(6) 1994; 6707-15, implanted: (b)(6) 2010; 5866-40m, implanted: (b)(6) 2010.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during laser lead extraction for a system upgrade, the patient required open heart surgery to repair a small tear in the right ventricle.A new system was implanted a few days later.No patient complications have been reported as a result of this event.

• Brand Name: 3.2 MM BI LEAD TO IS-1 BI IPG - PERMANENT EXTENSION, ADAPTOR KIT
• Common Device Name: ADAPTOR, LEAD, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 7877348
• Report Number: 2182208-2018-01692
• Device Sequence Number: 13486840
• Product Code: DTD
• UDI-Device Identifier: 00681490136952
• UDI-Public: 00681490136952
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K911302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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: 03/14/2011
• Device Model Number: 5866-40M
• Device Catalogue Number: 5866-40M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/14/2018
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR