MAUDE Adverse Event Report: MPRI ATTAIN OTW; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

Model Number 419478

Device Problems Intermittent Capture (1080); Crack (1135); Low impedance (2285); Deformation Due to Compressive Stress (2889)

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

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products :6949-65 lead, implanted: (b)(6) 2005.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a planned right ventricular lead revision procedure, the left ventricular lead had intermittent loss of capture and low pacing impedance when attached to the analyzer.When the physician opened the pocket, there was a "kink" in the visible segment and a breach of the outer insulation.The left ventricular lead was explanted and replaced.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN OTW
• 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: 8627898
• MDR Text Key: 145643626
• Report Number: 2649622-2019-08635
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/19/2007
• Device Model Number: 419478
• Device Catalogue Number: 419478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2019
• Date Device Manufactured: 08/02/2005
• 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: 6725 ADAPTOR, (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR