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

Model Number 479688

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

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

Event Date 02/16/2017

Event Type  malfunction  

Event Description

It was reported that during implant the physician had difficulty stably placing the left ventricular (lv) lead.It was also reported that the "helix portion of the lead never went through the vein selected for placement." a different lv lead was chosen and implanted.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the full lead was returned, analyzed, and no anomalies were found.The analyst noted that the lead passed introducer test, and no helix anomaly found.A good faith effort will be made to obtain the applicable information relevant to the report.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.

• Brand Name: ATTAIN STABILITY
• 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): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6469912
• MDR Text Key: 72194591
• Report Number: 2649622-2017-04464
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/12/2018
• Device Model Number: 479688
• Device Catalogue Number: 479688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2016
• 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: 66 YR
• Patient Weight: 65