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

Model Number 459888

Device Problems Device Contamination with Body Fluid (2317); Defective Device (2588); Activation, Positioning or Separation Problem (2906)

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

Event Date 05/14/2014

Event Type  malfunction  

Event Description

It was reported that during the implant procedure the physician had difficulty advancing the lead down the delivery catheter¿s ninety degree angle and that the wire was also difficult to advance down the lead.Therefore, the lead was pulled back out of the sheath and it was then noted that there was quite a bit of blood that looked to be inside the insulation.The lead was removed and a new lead was implanted instead.No patient complications have been reported as a result of this event.

Manufacturer Narrative

This event occurred outside the u.S.And patient information is not generally available due to confidentiality concerns.This model number is not approved for distribution in the united states; however, it is same/similar to a device marketed in the u.S.(b)(4).

Manufacturer Narrative

Product event summary: the full lead was returned, analyzed, and no anomalies were found.However, it was noted that the distal end/ electrodes of the lead were extrinsically damaged, the outer insulation of the lead was observed to have blood ingression, and visual summary analysis of the lead indicated damage at implant.Analysis comments noted that by design, left heart leads are manufacture d with a septum in the tip that will sometimes allow blood ingress.

Manufacturer Narrative

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

• Brand Name: ATTAIN PERFORMA
• 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: 3989421
• MDR Text Key: 4889616
• Report Number: 2649622-2014-07824
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 05/14/2014

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: 12/19/2015
• Device Model Number: 459888
• Device Catalogue Number: 459888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2014
• 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: 00084 YR