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

Model Number 429688

Device Problems Failure to Capture (1081); Pacing Problem (1439)

Patient Problem Syncope (1610)

Event Date 10/30/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant products: c2tr01 crt-p implanted (b)(6) 2015.

Event Description

It was reported that the patient presented to the emergency room after having collapsed.Right ventricular (rv) lead thresholds had risen and non-capture was observed.Output was increased with consistent capture and the lead remains in use.The physician also questioned if the left ventricular (lv) lead was pacing at the lower rate.It was determined that left ventricular pacing spikes were seen at the lower rate with no corresponding right ventricle-left ventricle complex.No changes were made to the left ventricular (lv) lead.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.

• 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: 6162263
• MDR Text Key: 62104261
• Report Number: 2649622-2016-15114
• 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,Followup
• Report Date: 10/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/24/2016
• Device Model Number: 429688
• Device Catalogue Number: 429688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2016
• Date Device Manufactured: 10/11/2014
• 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: 5076 LEAD (X2)
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 89 YR