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

Model Number 97714

Device Problem Human-Device Interface Problem (2949)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 07/01/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product(s): product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 015, explanted: (b)(6) 2015, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 08-sep-2018, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 21-jul-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The patient reported a loss of therapy.No falls or trauma were related.The patient had met with a manufacturer representative (rep) on the day of this report for reprogramming but this did not help the problems.She still was not getting pain relief ¿where it¿s helpful¿ and she had been dealing with this since (b)(6) 2015.Relevant medical history included spinal pain.Follow-up was performed to determine what actions were taken to address the issue and if the issue was resolved.Additional information was received from the patient.It was reported that the device was replaced in (b)(6) 2015 and they "had to do it three times".No further complications 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9531751
• MDR Text Key: 173252176
• Report Number: 3004209178-2019-24551
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2019
• Date Device Manufactured: 10/30/2014
• 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: 63 YR