MAUDE Adverse Event Report: MPRI ATTAIN ABILITY; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number	419678
Medical Device Problem Codes	Intermittent Capture (1080); Capturing Problem (2891); High Capture Threshold (3266)
Health Effect - Clinical Code	Non specific EKG/ECG Changes (1817)
Date of Event	07/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: c6tr01 crt-p, 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 episodes of asystole were observed on the monitor.Upon interrogation, the right ventricular (rv) lead threshold was found to be varying and unstable.It also noted that the left ventricular (lv) lead exhibited intermittent capture.The leads were reprogrammed and no further asystole was reported.The leads remain in use.A revision of both leads is planned for a future date.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.
Event or Problem Description
It was reported that the right ventricular (rv) lead had high increasing thresholds.The lead was programmed off and remain in the patient, out of service.A new rv lead was implanted from the right side of the patient.It was further reported that the lv lead had high increasing thresholds.The lv lead was programmed off and was not replaced.
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 pacing capture threshold in the left ventricle was high.Analysis of the device memory indicated pacing capture threshold issue in the left ventricle.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN ABILITY
• Common Device Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7812609
• Report Number: 2649622-2018-13883
• Device Sequence Number: 19131497
• Product Code: OJX
• UDI-Device Identifier: 00643169601765
• UDI-Public: 00643169601765
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2018

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: 10/24/2018
• Device Model Number: 419678
• Device Catalogue Number: 419678
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/06/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 09/05/2018; 09/07/2018
• 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: 4592-53 LEAD, 4092-58 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 88 YR