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

Model Number 419678

Device Problems Intermittent Capture (1080); Capturing Problem (2891); High Capture Threshold (3266)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 07/31/2018

Event Type  Injury  

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 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

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
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7812609
• MDR Text Key: 118112999
• Report Number: 2649622-2018-13883
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601765
• UDI-Public: 00643169601765
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/24/2018
• Device Model Number: 419678
• Device Catalogue Number: 419678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 08/24/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 09/06/2018
• Supplement Dates FDA Received: 09/05/2018; 09/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 4592-53 LEAD, 4092-58 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 88 YR