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

Model Number RVDR01

Device Problem Missing Test Results (3267)

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

Event Date 11/14/2013

Event Type  Injury  

Event Description

It was reported that after receiving radiation therapy, the patient¿s device interrogation revealed invalid data messages for battery voltage and other diagnostics caused by bit flips during radiation treatment.The diagnostics were cleared and the device continued to be used.One month later, during an in-office follow-up visit, diagnostics were collected, but lead trends showed invalid data and there was still no battery voltage measurement.It was recommended that the data collection setup be cleared using the initialize data feature.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: 5086mri52 implantable pacing lead, (b)(6) 2012; 5086mri58 implantable pacing lead, (b)(6) 2012.(b)(4).

Manufacturer Narrative

Product event summary: the actual product was not returned for analysis.However, performance data was collected from the device and was analyzed.Analysis of the device memory indicated the battery measurement was not available.Battery voltage not available due to bit flip in the lead impedance/battery voltage trend data.

• 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: 3616464
• MDR Text Key: 4154321
• Report Number: 3004209178-2014-02311
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/26/2013

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?: Yes
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 02/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2011
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 00084 YR