MAUDE Adverse Event Report: MEDTRONIC, INC. TWO IS-1 UNI LEADS TO IS-1 BI IPG ADAPTOR KIT; ADAPTOR, LEAD, PACEMAKER

Model Number	5866-38M
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: product id: dvfb1d1 icd, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that there was oversensing due to noise.It could not be identified whether the noise is coming from one of the leads or the adapter.The leads and adapter were abandoned due reduce risk of infection.New transvenous system was implanted.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the adaptor was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated oversensing associated with the right ventricular lead.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TWO IS-1 UNI LEADS TO IS-1 BI IPG 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: 8391116
• Report Number: 2182208-2019-00427
• Device Sequence Number: 19272836
• Product Code: DTD
• UDI-Device Identifier: 00681490136907
• UDI-Public: 00681490136907
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K911302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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: 03/14/2006
• Device Model Number: 5866-38M
• Device Catalogue Number: 5866-38M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 03/21/2019
• 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: 5071-35 LEAD, 5071-35 LEAD, 6721S-50 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 31 YR