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); Hematoma (1884); Unspecified Infection (1930); Swelling (2091)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 5076-52 lead; implanted (b)(6) 2012; 6947m62 lead; implanted (b)(6) 2012.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that an infection was suspected due to redness and swelling at the cardiac resynchronization therapy defibrillator (crt-d) pocket site.A hematoma was also noted.The pocket was reopened to collect blood cultures and the system was extracted the following day.The patient was treated with antibiotics.No further patient complications have been reported as a result of this event.

• 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: 9350232
• MDR Text Key: 167317364
• Report Number: 2649622-2019-21617
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/21/2013
• Device Model Number: 429688
• Device Catalogue Number: 429688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2019
• Date Device Manufactured: 11/03/2011
• 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: 66 YR