MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. REVO MRI SURESCAN; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

Model Number RVDR01

Device Problems Incorrect Measurement (1383); Unable to Obtain Readings (1516); Missing Test Results (3267)

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

Event Date 07/06/2016

Event Type  Injury  

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 likely due to bit flip in lead impedance/battery voltage trend data.

Event Description

It was reported that the implantable pulse generator (ipg) device showed invalid data with no battery voltage measurement available on the remote monitoring network.In addition, all of the patient information and lead information was wiped out, which was thought to be an issue with the random access memory (ram).The device was cleared and initialized, however the malfunction reoccurred on two separate occasions.The ipg was removed and replaced.The network remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis of the returned device was inconclusive.Analysis of the device memory indicated the battery measurement was not available.Pal analysis confirmed the invalid data and observed the battery voltage was unavailable on the 2090 programmer.System testing of the hardware and firmware used in generating a battery voltage were demonstrated to function nominally.The memory locations used to store the voltages measurements were demonstrated to function nominally.The cause of the invalid data in the system was unable to be determined; the analysis was inconclusive.

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 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6007840
• MDR Text Key: 56788962
• Report Number: 3004209178-2016-20954
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2016

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: 07/14/2016
• Device Model Number: RVDR01
• Device Catalogue Number: RVDR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2016
• Initial Date FDA Received: 10/06/2016
• Supplement Dates Manufacturer Received: Not provided; 12/12/2016
• Supplement Dates FDA Received: 02/09/2017; 09/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2015
• 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: 5076-52 LEAD, 5076-58 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR