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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Unintended Collision (1429)

Patient Problems Abscess (1690); Cyst(s) (1800); Pain (1994); Therapeutic Effects, Unexpected (2099); Weight Changes (2607)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 39565-65, serial# (b)(4), product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient with an implantable neurostimulator (ins) for the treatment of radicular pain syndrome (radiculopathies) and spinal pain.It was reported that the patient had a loss of stimulation.The patient reported that the stimulation was turning on and off by itself.The patient reported that they had an abscess/cyst in their leg and they were admitted into the hospital so that they could drain their leg.The patient reported that they were in a lot of pain and were shaking and convulsing.The patient was given steroids and now is only able to feel stimulation on the ¿top half.¿ the patient did not feel stimulation in their butt or legs.The patient tried to turn the stimulation up, but it became too high and they lowered it.The patient planned to meet with a manufacturer representative, who thought that the lead could be out of place.The patient noted that they have been in 4 car accidents and that they may have been up 20 lbs in weight.No further complications are anticipated.

Manufacturer Narrative

Device code - (b)(4) no longer applies to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp) via manufacturer representative (rep).It was reported that the rep was notified on 10/6 regarding the pain/abscess.Lead was in same place.No information on car accidents affecting the device/system.Cause of loss of stimulation was not determined.The rep reprogrammed on (b)(6).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: 9215691
• MDR Text Key: 163168039
• Report Number: 3004209178-2019-20065
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

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: 10/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 10/21/2019
• Supplement Dates FDA Received: 11/15/2019
• Date Device Manufactured: 11/26/2014
• 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): Hospitalization
• Patient Weight: 52