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

Model Number 429688

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Swelling (2091)

Event Date 09/13/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: dtma1d1 icd, implanted: (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that approximately four weeks after the implant of a new device, the patient woke up scratching at the implant site.Four days later the patient noticed increased redness, draining pus, mild tenderness and swelling around the site.The patient was subsequently seen in the emergency department where blood cultures were taken and the patient was started on antibiotics.The cardiac resynchronization therapy defibrillator (crt-d) system was explanted due to the pocket infection and a leadless implantable pulse generator (ipg) was implanted as a bridge.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the full lead was returned in segments, 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.

Event Description

Further information was received, which indicated the organism was identified as enterococcus faecalis.

• Brand Name: ATTAIN ABILITY PLUS MRI SURESCAN
• 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: 9236062
• MDR Text Key: 163744372
• Report Number: 2649622-2019-19664
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00613994719133
• UDI-Public: 00613994719133
• 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,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/02/2013
• Device Model Number: 429688
• Device Catalogue Number: 429688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2011
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 101