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

Model Number 419488

Device Problem Device Damaged by Another Device (2915)

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

Event Date 06/24/2013

Event Type  Injury  

Event Description

It was reported that the left ventricular lead experienced damage while explanting other leads.The left ventricular lead was explanted and replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: the lead was returned and analyzed and no anomalies were found.Visual analysis showed apparent explant damage and lead stretching.Concomitant medical products: 6949, implantable tachy lead, (b)(6) 2007; d224trk, implantable cardioverter defibrillator.(b)(4).

• 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): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 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: 4497894
• MDR Text Key: 5445029
• Report Number: 2649622-2015-02210
• Device Sequence Number: 1
• Product Code: LWP
• 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: Physician
• Type of Report: Initial
• Report Date: 11/21/2014

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: 09/27/2008
• Device Model Number: 419488
• Device Catalogue Number: 419488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2014
• Initial Date FDA Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2006
• 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: 5076 IMPLANTABLE PACING LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00053 YR