MAUDE Adverse Event Report: MEDTRONIC, INC.; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	6707-15
Medical Device Problem Codes	Mechanical Problem (1384); Low impedance (2285); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Muscle Stimulation (1412)
Date of Event	08/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 6707-15 adaptor, implanted (b)(6) 2017-08-24; 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 the patient was experiencing diaphragmatic stimulation.The right ventricular (rv) lead exhibited low impedance.The pace/sense rv coil and the superior vena cava (svc) coil were reversed in the device and the pace/sense pins were also reversed in the lead adaptor.The pocket was opened and the lead and the adaptor were placed in the proper positions in relation to the device and rv/svc coils.The adaptor remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the connector was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the impedance of the right ventricular pacing lead was below the expected lower range.Product id (b)(4).Lot# serial# (b)(4).Implanted: (b)(6).2017 explanted: if information is provided in the future, a supplemental report will be issued.

• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 6936272
• Report Number: 2182208-2017-01791
• Device Sequence Number: 10883340
• Product Code: LWS
• UDI-Device Identifier: 00613994793942
• UDI-Public: 00613994793942
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2018

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: 02/07/2019
• Device Model Number: 6707-15
• Device Catalogue Number: 6707-15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2017
• Supplement Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 02/08/2018
• 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; Required Intervention
• Patient Age: 61 YR