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

Model Number 419678

Device Problems Kinked (1339); Stretched (1601); Defective Device (2588); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)

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

Event Date 01/18/2016

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).

Event Description

It was reported that the lead was difficult to manipulate and had resistance after the sheath kinked.The lead ended up being stretched and the guide wire would not come out.The lead was replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary:the full lead was returned and analyzed.The distal conductor of the lead was obstructed due to a stylet/guidewire stuck in the lumen,the proximal conductor of the lead became extrinsically distorted due to pulling/stretching/overstress,the distal conductor of the lead became extrinsically distorted due to pulling/stretching/overstress,the inner insulation of the lead was extrinsically breached due to pulling/stretching/overstress,the inner insulation of the lead became extrinsically distorted due to kinking/buckling,visual summary analysis of the lead indicated damage at implant and visual summary analysis of the lead indicated stretching.The analyst also noted:guidewire could not be removed due to lead stretched: conductors distorted, insulation torn and buckled.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN ABILITY
• 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: 5557482
• MDR Text Key: 42765990
• Report Number: 2649622-2016-03053
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2016
• Device Model Number: 419678
• Device Catalogue Number: 419678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2014
• 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: 00072 YR