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

Model Number 97702

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Malaise (2359); Swelling/ Edema (4577)

Event Date 06/16/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 977a290, serial#: (b)(4) implanted: (b)(6) 2017, explanted: (b)(6) 2021, product type: lead, product id: 977a290, serial#: (b)(4), implanted: (b)(6)2017, explanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 977a290, serial/lot #:(b)(4), ubd: 06-oct-2018, udi#: (b)(4) ; product id: 977a290, serial/lot #: (b)(4), ubd: 11-apr-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins) for non-malignant pain.It was reported that patient reported receiving a haircut on (b)(6) 2021 and the next day at the anchor site he noticed redness/soreness.Over a period of 5 weeks swelling increased at this site and to the left of the anchor.Reported feeling ill during this time.Only thing the patient can think happened is possibly cut at anchor site during haircut.Patient went to see hcp to assess the redness and swelling.  explant surgery was performed on (b)(6) 2021.Patient explained surgeon told him the stimulator was infected and had to pull the entire system out.

• Brand Name: SURESCAN
• 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: 12032576
• MDR Text Key: 257198126
• Report Number: 3004209178-2021-09671
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169974883
• UDI-Public: 00643169974883
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2020
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2021
• Date Device Manufactured: 05/29/2019
• 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: 50 YR