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

Model Number 419678

Device Problems Device Dislodged or Dislocated (2923); High Capture Threshold (3266); Unstable Capture Threshold (3269)

Patient Problems Death (1802); Perforation of Vessels (2135); Cardiac Tamponade (2226)

Event Date 12/01/2013

Event Type  Death  

Event Description

It was reported that the left ventricular (lv) lead had high and inconsistent capture thresholds due to a dislodgement.During the procedure to explant the lead with a laser, the lv lead broke.As a result of the laser lead extraction there was an apparent venous dissection and perforation resulting in tamponade.As a result of the dissection the patient died during the procedure.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Concomitant products: 6947 lead, implanted: (b)(6) 2010; 5076 lead, implanted: (b)(6) 2010.(b)(4).

Manufacturer Narrative

Product event summary # product id# 419678 a medial portion was received measuring 18 cm.Analysis was performed and no anomalies were found, visual summary analysis of the lead indicated apparent explant damage.

• 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): 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: 3754572
• MDR Text Key: 4414154
• Report Number: 2649622-2014-04583
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/04/2010
• Device Model Number: 419678
• Device Catalogue Number: 419678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2014
• Initial Date FDA Received: 04/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2010
• 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
• Treatment: D314TRG ICD IMPLANTED (B)(6) 2013
• Patient Outcome(s): Death
• Patient Age: 00056 YR
• Patient Weight: 53