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

Model Number 419488

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was further reported that the lead had been deactivated sometime after implant and was non-functioning at the time of explant.

Manufacturer Narrative

Product event summary: the full lead was returned in segments, analyzed.The outer insulation of the lead developed a breach due to environmental stress cracking while in vivo.If information is provided in the future, a supplemental report will be issued.

Event Description

The lead was returned to the manufacturer, analyzed and tested out of specification.No patient complications have been reported as a result of this event.

• 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: 9447248
• MDR Text Key: 173645082
• Report Number: 2649622-2019-23075
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00885074113371
• UDI-Public: 00885074113371
• Combination Product (y/n): N
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/08/2011
• Device Model Number: 419488
• Device Catalogue Number: 419488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Date Manufacturer Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2009
• 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