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

Model Number 97714

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

Patient Problems Irritation (1941); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977c265, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.Other relevant device(s) are: product id: 977c265, serial/lot #: (b)(4), ubd: 14-jul-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received via a manufacturer representative from a consumer regarding a patient who is implanted with a neurostimulator.It was reported that the patient believed that she could feel the lead under her skin and it had been bothering her.She did not have pain but believed she felt irritation.The physician made an incision for inspection on (b)(6) 2019 and the lead was securely in place as well as the anchors.The physician found nothing wrong with the lead.They sutured around the anchors to ensure stability.The issue was resolved at the time of the report.There were no further complications reported or anticipated.

• Brand Name: SURESCAN
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8735207
• MDR Text Key: 149213136
• Report Number: 3004209178-2019-12391
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2019
• Date Device Manufactured: 08/24/2017
• 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: 57 YR