MAUDE Adverse Event Report: MEDTRONIC, INC. DF-1 Y-ADAPTOR/EXTENDER KIT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	672625
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: model: 694765, lead; implanted: (b)(6) 2004.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient's right ventricular (rv) lead had triggered an alert for high/undefined superior vena cava (svc) de fibrillation coil impedance.It was further discovered that the rv defibrillation coil impedance displayed high/undefined impedance and there was a small amount of noisy electrograms (egm) involving the rv coil.Additionally, the rv tip-to-rv coil lead impedance had triggered a warning for high/undefined impedance, but the lead is currently programmed to a bipolar configuration.A lead fracture is suspected.It was noted that the patient has lead extenders connected to both the svc coil and rv coil connections and it is unclear if the suspected fracture is on the lead or the extenders.Follow up was conducted and it has been verified that no reprogramming nor intervention has been completed at this time.The lead and extenders all remain in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the lead 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 defibrillation coil was beyond the expected upper range.Analysis of the device memory indicated the impedance of the superior vena cava defibrillation coil was beyond the expected upper range.It is not possible to determine if the high impedance readings are traced to the lead or the lead extenders.It is also not known which adapter is for the rv and which is for the svc circuit.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that the right ventricular (rv) lead and lead extenders were removed.A new implantable cardioverter defibrillator (icd) system was implanted in the right pectoral area.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the full lead was returned in segments, analyzed, and no anomalies were found.Visual analysis of the lead indicated apparent explant damage.The analyst noted the full lead extender was received in pieces.No anomalies were found with the distal lead adaptor and the set screws functioned normally.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DF-1 Y-ADAPTOR/EXTENDER KIT
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 8066808
• Report Number: 2182208-2018-02070
• Device Sequence Number: 16642100
• Product Code: LWS
• UDI-Device Identifier: 00721902066801
• UDI-Public: 00721902066801
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/23/2020

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: 06/01/2020
• Device Model Number: 672625
• Device Catalogue Number: 672625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 10/19/2018; 11/26/2018; 01/23/2020
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 11/13/2018; 11/27/2018; 01/23/2020
• 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: 73 YR