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

Model Number 419478

Device Problem Failure to Capture (1081)

Patient Problem Heart Failure (2206)

Event Date 10/25/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 6947m62 lead, implanted (b)(6) 2014.Dtma1d4 crt-d, implanted (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was hospitalized with decompensated heart failure.It was further reported that the left ventricular (lv) lead exhibited complete loss of capture in all vectors.The lv lead remains in use.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: 9452867
• MDR Text Key: 170308897
• Report Number: 2649622-2019-23240
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00885074113364
• UDI-Public: 00885074113364
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/06/2007
• Device Model Number: 419478
• Device Catalogue Number: 419478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2005
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Weight: 87