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	Electrical /Electronic Property Problem (1198); Connection Problem (2900)
Health Effect - Clinical Code	Syncope (1610)
Date of Event	06/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: 4968-35 lead implanted: (b)(6) 2011; 4965-35 lead implanted (b)(6) 2011; (b)(4) lead implanted (b)(6) 2016; (b)(4) icd implanted (b)(6) 2016.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 or Problem Description
It was reported the patient experienced high defibrillation thresholds.Approximately six months later a defibrillation lead was implanted and seventeen defibrillation tests were performed.After the patient returned home, pre-syncopal episodes were experienced and re-programming was performed.This was followed by changing the sensitivity.It was later determined the adaptor was not fully inserted into the right ventricular pace/sense port on the device.The adaptor was disconnected from the rv port and reconnected.The connection was tested and the adaptor remains in use.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.

• 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: 6501099
• Report Number: 2182208-2017-00682
• Device Sequence Number: 10947397
• Product Code: DTD
• UDI-Device Identifier: 00681490136907
• UDI-Public: 00681490136907
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K911302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2017

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: 08/14/2012
• Device Model Number: 5866-38M
• Device Catalogue Number: 5866-38M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2017
• Supplement Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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: 6721S-50 LEAD, 6937A-52 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 19 YR