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

Model Number 97715

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

Patient Problems Unspecified Infection (1930); Pocket Erosion (2013); Skin Erosion (2075)

Event Date 05/13/2021

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 977c265, serial/lot #: (b)(4), ubd: 22-aug-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient had erosion of skin over generator (ins); pocket erosion.The patient had been bed bound due to other medical issues and had been lying on device for some time.The patient was seen by neurosurgery and it was determined to have device removed due to possible infection.The generator and lead were surgically removed and the issue was resolved.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: 11831990
• MDR Text Key: 250853134
• Report Number: 3004209178-2021-07793
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2021
• Date Device Manufactured: 11/16/2019
• 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
• Patient Age: 76 YR