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

Model Number 4298

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Perforation of Vessels (2135)

Event Date 02/05/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported the implant procedure was aborted due to complications.Additional information was requested, and it was learned there was difficulty locating a target branch.It was also reported the guide wire, catheter, and lead continually slipped out of the coronary sinus, the procedure lasted for hours, and the patient endured perforations due to wire placements.A review of the manufacturers data base revealed the patient is deceased.No other information is known at this time.

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): MEDTRONIC, PLC; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, PLC; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7303124
• MDR Text Key: 101166702
• Report Number: 2182208-2018-00321
• Device Sequence Number: 1
• Product Code: OJX
• 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: 03/01/2018

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?: No
• Device Operator: Physician
• Device Model Number: 4298
• Device Catalogue Number: 4298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 02/05/2018
• Supplement Dates FDA Received: 03/01/2018
• 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: 6250V-3D CATHETER, UNKNOWN COMPETITOR GUIDE WIRE
• Patient Outcome(s): Death; Hospitalization; Life Threatening
• Patient Age: 60 YR