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

Model Number W1TR01

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332); Incorrect Measurement (1383); Pacing Problem (1439); Unable to Obtain Readings (1516)

Patient Problems Syncope (1610); Bradycardia (1751)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 4196-88 lead, implanted: (b)(6) 2013.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented to the hospital after a syncopal episode and symptomatic bradycardia.The cardiac resynchronization therapy pacemaker (crt-p) was unable to be interrogated.A second programmer was attempted to obtain telemetry to no avail.A magnet was placed over the device and was unable to elicit a magnet response and there was no pacing output observed.It was also noted the patient had a treated atrial fibrillation (af) episode and when the episode list was selected to download detail, an "invalid data" message appeared and the episode detail was unable to be obtained.Premature battery depletion was suspected and the device was explanted and replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Hybrid analysis found the battery depletion was due to a leaky c12 ceramic capacitor.Computed tomography scanning of c12 revealed evidence of a curved fracture crossing electrode plates.Silver migrating from the agpd electrodes is known to fill this type of fracture and provide a conductive path (short) between the electrodes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PERCEPTA 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: 8697408
• MDR Text Key: 147943079
• Report Number: 3004209178-2019-11573
• 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
• Type of Report: Initial,Followup
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2020
• Device Model Number: W1TR01
• Device Catalogue Number: W1TR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2019
• 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: 5086MRI52 LEAD, 5086MRI58 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 81 YR