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

Model Number 419678

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 07/15/2014

Event Type  malfunction  

Event Description

It was reported that during an implant attempt, the stylet became stuck at the proximal portion of the left ventricular (lv) lead, near the connector.The physician commented that the insulation appeared abnormal, and noted blood in the inner insulation.Impedances and other electrical measurements were in range, but the lead was implanted.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: the full lead was returned and analyzed.The proximal conductor of the lead became extrinsically distorted due to pulling/stretching/overstress.There was blood on the distal conductor of the lead and it was not obstructed.Visual summary analysis of the lead indicated damage at implant.(b)(4).

• 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: 4164512
• MDR Text Key: 4867795
• Report Number: 2649622-2014-12931
• 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
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2016
• Device Model Number: 419678
• Device Catalogue Number: 419678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2014
• 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
• Treatment: 2088TC ST. JUDE LEAD
• Patient Outcome(s): Hospitalization
• Patient Age: 00079 YR