MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VERSA IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number VEDR01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/15/2020

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 experienced an incident and "had a terrible time" with the implantable pulse generator (ipg).The ipg remains in use.No patient complications have been reported as a result of this event.

• Brand Name: VERSA IPG
• 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: 10641015
• MDR Text Key: 210201296
• Report Number: 3004209178-2020-17371
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00613994222114
• UDI-Public: 00613994222114
• 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: 10/07/2020

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: 02/14/2016
• Device Model Number: VEDR01
• Device Catalogue Number: VEDR01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/07/2020
• Date Device Manufactured: 08/14/2014
• 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: 5076-58 LEAD, 5076-52 LEAD
• Patient Age: 91 YR