MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SOLARA QUAD CRTP; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

Model Number W4TR03

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

Patient Problems Ecchymosis (1818); Erythema (1840); Hematoma (1884); Unspecified Infection (1930); Pocket Erosion (2013); Swelling (2091)

Event Date 04/07/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 4798 lead, implanted (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that about two weeks after a lead revision, the patient experienced a pocket hematoma with swelling and drainage; a large area of ecchymosis was noted.Antibiotic was started and the device remained in use.The patient later presented to the emergency department for drainage of the hematoma, and was discharged the same day.Three days later, oozing restarted with pocket erythema.A new intravenous (iv) medication was given.Bleeding from the device site when occurred about five days later and the cardiac resynchronization therapy pacemaker (crt-p) system was explanted and replaced due to an infection and pocket erosion.The patient was a participant in the attain stability quad study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary : the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SOLARA QUAD CRTP
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7587755
• MDR Text Key: 110638990
• Report Number: 3004209178-2018-13101
• 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,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2019
• Device Model Number: W4TR03
• Device Catalogue Number: W4TR03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2017
• 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: 4076 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 95