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

Model Number 439688

Device Problems Device Contamination with Body Fluid (2317); Device Dislodged or Dislocated (2923)

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

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that once the left ventricular (lv) lead was placed, the lead "felt off" after sheathing.Blood had ingressed the lead, making wire operation difficult.The lead was removed and a different lead was implanted.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the full lead was returned and analyzed and no anomalies were found.Visual analysis of the lead indicated damage at implant.The analyst noted that the lead was designed with a permeable septum in the distal tip with allowed blood ingression to occur.This was not an out of specification condition.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

The lead reportedly "fell off", meaning the lead had dislodged from the target vessel into the atrium.

• Brand Name: ATTAIN ABILITY STRAIGHT
• 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): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8286683
• MDR Text Key: 134395508
• Report Number: 2649622-2019-01514
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2020
• Device Model Number: 439688
• Device Catalogue Number: 439688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 03/05/2019; 06/05/2019
• Supplement Dates FDA Received: 03/05/2019; 06/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2018
• 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: 70 YR