MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO REVO MRI SURESCAN; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

Model Number RVDR01

Device Problems Incorrect Measurement (1383); Unable to Obtain Readings (1516); Inappropriate or Unexpected Reset (2959); Missing Test Results (3267)

Patient Problem Bradycardia (1751)

Event Date 04/16/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient experienced bradycardia.A remote transmission report indicated that a partial electrical reset occurred with the implantable pulse generator (ipg).It was additionally noted that the patient had just completed radiotherapy.The device was reprogrammed and remains in use.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

It was further reported that there was no battery data or lead trend information available from the ipg, and a bit flip was observed.The patient was brought to the clinic to initialize data on the pacemaker.The device remains in use.

Manufacturer Narrative

Correction: the aware date of new device information was (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated a power on reset occurred.Analysis of the device memory indicated an issue with missing/invalid diagnostic data.Analysis of the device memory indicated the lead impedance data was missing/invalid.Analysis of the device memory indicated the battery measurement was not available.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: REVO MRI SURESCAN
• Type of Device: PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7503964
• MDR Text Key: 107904189
• Report Number: 3004209178-2018-10611
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00613994614742
• UDI-Public: 00613994614742
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2013
• Device Model Number: RVDR01
• Device Catalogue Number: RVDR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 04/18/2018; 04/18/2018; 07/25/2018; 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 07/18/2018; 07/18/2018; 08/03/2018; 10/03/2018; 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2011
• 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: 507652 LEAD, 507645 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR