MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SOLARA QUAD CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

Model Number W4TR03

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

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

Event Date 01/06/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: cmrm6133 envelope; implanted (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that approximately one month after implant of the cardiac resynchronization therapy pacemaker (crt-p) and antibacterial absorbable envelope, the patient reported redness at the incision site that was warm to the touch with purulent drainage.A small open area was noted.The patient was treated with oral antibiotics.The incision was later noted to be healed.The device remains in use.The patient is a participant in the post approval clinical surveillance product surveillance registry.No further patient complications have been reported as a result of this event.

• Brand Name: SOLARA QUAD CRT-P MRI SURESCAN
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9262832
• MDR Text Key: 164601543
• Report Number: 3004209178-2019-20824
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169735682
• UDI-Public: 00643169735682
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010015
• 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: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2020
• Device Model Number: W4TR03
• Device Catalogue Number: W4TR03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2019
• Date Device Manufactured: 10/29/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 82