MAUDE Adverse Event Report: MPRI ATTAIN PERFORMA; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 429888

Device Problem Device Handling Problem (3265)

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

Event Date 04/03/2014

Event Type  malfunction  

Event Description

It was reported that during implant attempt, it was impossible to "get out the lead outside of the catheguide." the lead was not used.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.This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.This model number is not approved for distribution in the united states, however, it is similar to a device marketed in the u.S.The event is being reported due to an alleged malfunction.(b)(4).Evaluation summary: analysis was performed and no anomalies were found, however visual summary analysis of the lead indicated damage at implant; full lead returned and analyzed.

• Brand Name: ATTAIN PERFORMA
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3989457
• MDR Text Key: 4750948
• Report Number: 2649622-2014-07804
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2016
• Device Model Number: 429888
• Device Catalogue Number: 429888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2014
• Initial Date FDA Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2014
• 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
• Patient Age: 00077 YR