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

Model Number 419688

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Purulent Discharge (1812); Fatigue (1849); Headache (1880); Unspecified Infection (1930); Pain (1994); Skin Erosion (2075); Swelling (2091)

Event Date 01/10/2019

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 patient was seen with complaints of fatigue, headache and pain and swelling at the pocket site.Dehiscense was noted along with skin erosion with a bare wire being visible.There was also purulent drainage with a likely infection.The lead was explanted and will possibly be replaced at a later date.The patient was placed on antibiotic therapy.No further 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 apparent explant damage.If information is provided in the future, a supplemental report will be issued.

• 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): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8359108
• MDR Text Key: 136785348
• Report Number: 2649622-2019-02886
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00613994469731
• UDI-Public: 00613994469731
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/06/2017
• Device Model Number: 419688
• Device Catalogue Number: 419688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2015
• 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: 382884 LEAD, 384105 LEAD, TDF012U ICD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR