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

Model Number W4TR02

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 429888, lead, implanted (b)(6) 2019.Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the lead impedance data was missing/invalid.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the cardiac resynchronization therapy pacemaker (crt-p) exhibited invalid polarity parameter displayed as question marks in the left ventricular (lv) lead impedance trend, which was caused by a bit flip.The device remains in use.No patient complications have been reported as a result of this event.

• Brand Name: SERENA 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: 10205747
• MDR Text Key: 196859992
• Report Number: 3004209178-2020-11197
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169735668
• UDI-Public: 00643169735668
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2020
• Device Model Number: W4TR02
• Device Catalogue Number: W4TR02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2019
• 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: 5076-58 LEAD, 5076-45 LEAD
• Patient Age: 85 YR