MAUDE Adverse Event Report: MPRI ATTAIN BIPOLAR OVER THE WIRE LEAD; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

Model Number 419488

Device Problem Failure to Capture (1081)

Patient Problem Occlusion (1984)

Event Date 04/05/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: dtba1d1 crt-d, implanted: (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was no capture on the left ventricular (lv) lead and it was programmed off.The patient was brought in, at a later date, for a lead revision.It was noted that the lead could not be revised due to an occlusion.The lead remains inactivated.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 BIPOLAR OVER THE WIRE LEAD
• Type of Device: PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9403729
• MDR Text Key: 168870438
• Report Number: 2649622-2019-22480
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00885074113371
• UDI-Public: 00885074113371
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

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: 04/01/2011
• Device Model Number: 419488
• Device Catalogue Number: 419488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 12/03/2019
• Supplement Dates Manufacturer Received: 12/04/2019
• Supplement Dates FDA Received: 12/06/2019
• Date Device Manufactured: 04/16/2009
• 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: 58 YR