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

Model Number W1TR01

Device Problems Nonstandard Device (1420); Pocket Stimulation (1463); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Death (1802); Unspecified Infection (1930); Pocket Erosion (2013); Sepsis (2067)

Event Date 06/25/2018

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: 4968-35 lead implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient developed pocket erosion and infection.The cardiac resynchronization therapy pacemaker (crt-p) was removed, the intravenous leads were removed and the existing epicardial left ventricular (lv) lead was tunneled out below the pocket and connected to the externalized crt-pt to provide temporary pacing support during antibiotic and wound therapy.The epicardial lead and crt-p will be replaced at a later date.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received, which indicated the patient passed away approximately 6 weeks later due to sepsis.

Manufacturer Narrative

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

• Brand Name: PERCEPTA 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: 7707545
• MDR Text Key: 114614916
• Report Number: 3004209178-2018-16334
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169735637
• UDI-Public: 00643169735637
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

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: 12/28/2018
• Device Model Number: W1TR01
• Device Catalogue Number: W1TR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/20/2018
• Supplement Dates Manufacturer Received: 06/25/2018; 08/08/2018
• Supplement Dates FDA Received: 09/05/2018; 10/04/2018
• Date Device Manufactured: 07/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2412-2018
• Patient Sequence Number: 1
• Treatment: 5076-52 LEAD, 5076-45 LEAD
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 59