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

Model Number 429888

Device Problems High Sensing Threshold (2574); High Capture Threshold (3266)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: dtbb1q1 crtd implanted: (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the left ventricular (lv) lead exhibited high thresholds in all vectors.The lv lead was explanted and replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the full lead was returned and analyzed.No anomalies were found.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: ATTAIN PERFORMA
• 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: 7699918
• MDR Text Key: 114359199
• Report Number: 2649622-2018-11724
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169002715
• UDI-Public: 00643169002715
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/11/2017
• Device Model Number: 429888
• Device Catalogue Number: 429888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2015
• 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: 407652 LEAD, 694765 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR