MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS VITATRON MRI SURESCAN, G70 DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number G70A2

Device Problem Mechanical Problem (1384)

Patient Problems Muscle Stimulation (1412); Palpitations (2467)

Event Date 08/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported patient experienced chest muscle pacing, heart palpitations and generally did not feel well.The implantable pulse generator (ipg) exhibited a set screw problem.The device was replaced.It was additionally noted that both the initial device and the replacement device were in scope of the advisory describing the potential for device circuit error to occur while the device is processing an atrial-sensed event, the implantable pulse generator (ipg).No device malfunction was observed while the device was in use related to the circuit error.The replacement device remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: VITATRON MRI SURESCAN, G70 DR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SG 486056
• Manufacturer (Section G): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SG 486056
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9099480
• MDR Text Key: 159519391
• Report Number: 3008973940-2019-02605
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2019
• Device Model Number: G70A2
• Device Catalogue Number: G70A2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/20/2019
• Date Device Manufactured: 03/26/2018
• 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: 2088TC-52 LEAD, 4076-52 LEAD
• Patient Age: 76 YR