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

Model Number A2DR01

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported by the patient that they think their body is "rejecting" the implantable pulse generator (ipg).Patient reported the device keeps "shifting to the left".The ipg remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: ADVISA 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: 10770364
• MDR Text Key: 214173464
• Report Number: 3004209178-2020-19083
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00643169493377
• UDI-Public: 00643169493377
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/02/2020

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: 04/14/2018
• Device Model Number: A2DR01
• Device Catalogue Number: A2DR01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 11/02/2020
• Date Device Manufactured: 10/17/2016
• 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 Age: 80 YR