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

Model Number 459888

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

Patient Problems Unspecified Infection (1930); Necrosis (1971)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that approximately five-months post implant procedure, the patient cardiac resynchronization therapy defibrillator (crt-d) eroded through the skin in the lateral upper corner with minimal drainage.During the explant procedure, it was noted that pocket was infected with fibrous thickening of the capsule and necrotic tissue.Antibiotics was administered, and the crt-d system was removed.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the proximal portion of the lead was returned, 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 PERFORMA S 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: 8633110
• MDR Text Key: 145832564
• Report Number: 2649622-2019-08761
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601871
• UDI-Public: 00643169601871
• 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: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/06/2020
• Device Model Number: 459888
• Device Catalogue Number: 459888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 05/23/2019
• Supplement Dates FDA Received: 05/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2018
• 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
• Treatment: DTMA1QQ ICD, 5076-52 LEAD, 6935M62 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR