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

Model Number 97702

Device Problem Malposition of Device (2616)

Patient Problems Irritation (1941); Scar Tissue (2060); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 09/30/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2015, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 15-jan-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient regarding their implantable neurostimulator (ins).Information was reported that the therapy doesn't seem to do any good any longer, and the therapy never really helped both of the patient's legs like it was intended to because they couldn't get the lead placement correct due to scare tissue from a previous surgery.The patient reported he is starting to feel irritation and discomfort like someone is sticking a needle in them since six months ago.The patient asked if any healthcare provider (hcp) could remove the ins because his hcp moved away and the other hcp didn't want to touch the ins.No further complications were reported.No additional patient symptoms were reported.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10038328
• MDR Text Key: 190336146
• Report Number: 3004209178-2020-08295
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2016
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2020
• Date Device Manufactured: 02/11/2015
• 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 Age: 71 YR