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

Model Number 429688

Device Problem Failure to Capture (1081)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: dtma1d1 crt-d implanted: (b)(6) 2018 1646t lead implanted: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that since implant the right ventricular (rv) lead has exhibited rising, unstable, and undefined impedance and high threshold.The left ventricular (lv) lead exhibited loss of capture on telemetry and was reprogrammed.It was noted the patient experienced symptomatic pauses.It was noted there was a set screw problem with the cardiac resynchronization therapy defibrillator (crt-d).The leads were reseated and set screw torqued.The device and leads remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN ABILITY PLUS
• 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: 7823643
• MDR Text Key: 118459609
• Report Number: 2649622-2018-14059
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00613994719133
• UDI-Public: 00613994719133
• 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
• Report Date: 08/28/2018

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: 05/02/2014
• Device Model Number: 429688
• Device Catalogue Number: 429688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2012
• 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: 1642 LEAD, 694765 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR