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 Problem (1431); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins) for multiple back operations and spinal pain.It was indicated that the patient had a medical history of failed back surgery syndrome, spinal cord stimulator discectomy and laminectomy ((b)(6) 2018).It was reported that the patient called and wanted reprogramming as they had back surgery (eg.Discectomy and laminectomy) on (b)(6) and their foot pain was worse and the stimulation doesn't touch the pain.It was indicated that the surgery on (b)(6) may have led or contributed to their issue.It was indicated that they would meet with the patient on (b)(6).The issue was not resolved at the time of the report.No surgical intervention occurred or was planned.No further complications were reported/anticipated.

Manufacturer Narrative

Contains all applicable codes regarding this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer representative on (b)(6) 2018 reporting that per the consumer they felt much better and their pain was covered better after the programming session performed on the day of the report (b)(6) 2018.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 7664122
• MDR Text Key: 113252233
• Report Number: 3004209178-2018-15062
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 05/18/2017
• 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 Age: 60 YR
• Patient Weight: 82