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

Model Number 97714

Device Problems Energy Output To Patient Tissue Incorrect (1209); Charging Problem (2892); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 01/29/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 37751, serial# (b)(4), product type: recharger; product id: 977c165, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.Other relevant device(s) are: product id: 977c165, serial/lot #: (b)(4), (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received regarding a patient with an implantable neurostimulator (ins), and it was reported that the patient was having an mri to check on a suspected issue with the patient's leads.The caller did not know what the issue was and had no other information.Additional information received stated that the patient could not power the recharger, and has not used it for 4 months but can feel the ins working in her back "real low, like maybe a one" over the past 4 months.The patient states she's "had it out for a 1/2 hour with the battery working".The patient noted the connector pin for the dtc did not appear loose or bent, and the desktop charger light was on.The patient reported that neither the patient programmer nor the recharger were working to connect, and the patient wanted to put the device in mri mode.Patient was issued a new recharger.Additional information received stated that the patient was unable to charge with the new recharger, and the patient had turned the ins off and stopped charging 3 months ago.The patient was redirected to their hcp.The patient reported that the mri was being done to check the implanted system before removal.The patient reported the implanted system was to be removed because it was not working and was worse than "what he was like before".It was clarified that the patient was worse with the ins therapy than before, and though the ins was off the patient could feel it.There were no reported complications and no further complications were expected.Patient was implanted for movement disorders.

• 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: 7464573
• MDR Text Key: 106612287
• Report Number: 3004209178-2018-09332
• 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,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/29/2016
• 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: 54 YR