MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ADVISA SR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number A3SR01

Device Problems Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Over-Sensing (1438); Pacing Problem (1439); Under-Sensing (1661); Decreased Sensitivity (2534)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 right ventricular (rv) his bundle lead exhibited oversensing, short v-v intervals, with isometrics eliciting myopotential noise, which caused pacing inhibition and, furthermore, rare under-sensing with low amplitude r-waves was observed.It was also reported that the implantable pulse generator (ipg) exhibited oversensing of short v-v intervals and ventricular tachycardia (vt) episodes, consistent with electromagnetic interference (emi), with isometrics eliciting myopotential noise, which caused pacing inhibition and, furthermore, rare under-sensing with low amplitude r-waves was observed.Diagnostic testing/troubleshooting was performed and both the ipg and the rv lead were reprogrammed.Three days later, the single chamber ipg was explanted and replaced with a dual chamber ipg.The existing rv his bundle lead was moved to the atrial port and remains in use, with an additional rv septal lead added to the ventricular port.No patient complications have been reported as a result of this event.

• Brand Name: ADVISA SR MRI SURESCAN
• Type of Device: PULSE GENERATOR, PERMANENT, 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 12167568
• MDR Text Key: 261519688
• Report Number: 3004209178-2021-10832
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00643169402669
• UDI-Public: 00643169402669
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2021

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: 07/28/2019
• Device Model Number: A3SR01
• Device Catalogue Number: A3SR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/14/2021
• Date Device Manufactured: 02/08/2018
• 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: 383069 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention