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

Model Number 429688

Device Problems Device Contamination with Body Fluid (2317); High Capture Threshold (3266)

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

Event Date 06/30/2014

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the full lead was returned and analyzed.Analysis was performed and no anomalies were found.The outer insulation of the lead was observed to have blood ingression.Visual summary analysis of the lead indicated damage at implant.

Event Description

It was reported that during an implant attempt, the left ventricular (lv) lead was positioned in the coronary sinus and had high thresholds.The physician noted there was quite a lot of blood inside the lead when it was extracted from the body.Another lead was implanted.No patient complications have been reported as a result of this event.

Manufacturer Narrative

This event occurred outside the us where a similar 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

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

• Brand Name: ATTAIN ABILITY PLUS
• 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: 3990136
• MDR Text Key: 12267822
• Report Number: 3008973940-2014-00288
• 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: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2015
• Device Model Number: 429688
• Device Catalogue Number: 429688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2013
• 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: 00079 YR
• Patient Weight: 69