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

Model Number 439688

Device Problems Detachment Of Device Component (1104); Fracture (1260); Mechanical Problem (1384); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)

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

Event Date 01/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the left ventricular (lv) lead exhibited a high pacing threshold and an extraction was planned.While using a laser to extract the lead, the physician had to pull hard in order for the lead to loosen and the lv lead became dislodged to be removed.It was noted when the physician was pulling, the lead pulled apart in such a way that the insulation came out of the lead itself and the distal portion containing the bipolar electrodes could not get out of the venous anatomy before the lead fractured.The two distal electrodes of the lead broke off from the remainder of the lead and still remain in the lateral vein of the patients heart, seeing as there was no means to retrieve it.At the time, it was difficult to tell if there was any conductor or insulation left connecting the two electrodes, as on fluoroscopy it looked like there was nothing between the electrodes and "they are just floating in place." the rest of the lv lead was removed and the lv lead was replaced.No patient complications have been reported as a result of this event.

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7415037
• MDR Text Key: 104963390
• Report Number: 2649622-2018-03751
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00613994719058
• UDI-Public: 00613994719058
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/09/2016
• Device Model Number: 439688
• Device Catalogue Number: 439688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2018
• Date Device Manufactured: 03/11/2014
• 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: THE 6935M62 LEAD, 5076-52 LEAD, DTBA1D4 DEVICE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR