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

Model Number RVDR01

Device Problems Unable to Obtain Readings (1516); Missing Test Results (3267)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2014

Event Type  Injury  

Event Description

It was reported that the implantable pulse generator (ipg) device was interrogated and the battery voltage was not available.Invalid data with question marks was displayed for all the pacing percentages.The device memory was restored by re-initializing data collection.The device remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Concomitant medical products: 5086mri45, lead, implanted (b)(6) 2012.(b)(4).

• Brand Name: REVO MRI SURESCAN
• Type of Device: PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3993321
• MDR Text Key: 4888181
• Report Number: 3004209178-2014-14648
• Device Sequence Number: 1
• Product Code: LWP
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/29/2014

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: 07/14/2013
• Device Model Number: RVDR01
• Device Catalogue Number: RVDR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2014
• Initial Date FDA Received: 08/08/2014
• Date Device Manufactured: 01/17/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 00070 YR