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

Model Number 419688

Device Problems Device Contamination with Body Fluid (2317); Activation, Positioning or Separation Problem (2906)

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

Event Date 11/12/2013

Event Type  malfunction  

Event Description

It was reported that during the implant procedure, several attempts had been made to place the lead in the target vessel when the guidewire could not move through the tip of the lead.When the lead was removed, blood was noted to be inside the lead.No left ventricular lead was implanted.No patient complications have been reported as a result of this event.

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).

Manufacturer Narrative

Product event summary: the full lead was returned, analyzed, and there was blood on the distal conductor of the lead and it was obstructed.Visual summary analysis of the lead indicated damage at implant.

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): MEDTRONIC SINGAPORE OPERATIONS; nasaco tech centre, 49 changi; singapore ; SG
• 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: 3615859
• MDR Text Key: 4158356
• Report Number: 3008973940-2014-00034
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2015
• Device Model Number: 419688
• Device Catalogue Number: 419688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2013
• 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: 00064 YR