MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97715

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome.It was reported that the patient stated they had an explant done where the healthcare provider removed the lead and battery.This was due to an infection at the battery site.When the manufacturer representative (rep) asked when the infection/explant occurred, the patient said months ago.The rep was not informed of the infection or explant.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12331207
• MDR Text Key: 266879115
• Report Number: 3004209178-2021-12487
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2021
• Date Device Manufactured: 09/26/2019
• 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
• Patient Outcome(s): Required Intervention