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

Model Number 97714

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Headache (1880); Itching Sensation (1943); Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Discomfort (2330); Reaction (2414); Neck Pain (2433); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

A consumer implanted for non-malignant pain reported via the manufacturer's representative (rep) the consumer was experiencing back pain and issues walking.According to the rep.The consumer felt like they were shuffling when walking.The consumer called their healthcare provider (hcp), but there was no response.Patient noted that they were implanted for complex regional pain syndrome (crps) that caused unbearable pain in the shoulder, neck, down the right arm, and it causes headaches.Patient noted the crps started after they'd been injured.Patient stated that the crps symptoms seem to be lessened with the implant/therapy.Patient stated the intense itching was driving her insane and she could not sleep the night before the date of this event because of itching.They kept trying to put cortisone on the itching areas, but it didn't help.The itching occurs in sporadic "hot spots" on their legs, groin, torso, arms, hands, and everywhere but the legs.There were not any marks or bumps on the skin aside from the marks created by the patient scratching their skin.Patient also mentioned another medical issue, noting that they were feeling stinging, burning, pinching, and pain on the left side of their body surrounding the ins implant site.Patient noted that it was not occurring directly at the site, but was surrounding it.Patient stated they were now having pain where they never had pain before.The pain sometimes goes to their rib and abdomen, radiating all the way up the left side from the shoulder blade to the ins site.The skin was tender to the touch.Patient noted that it has improved a bit but was still ongoing.They mentioned there were no visible marks, but the issues seemed to be "inside her." patient stated that they had a real bad skin reaction that felt like a burn right after they were implanted.Patient stated that they'd stayed in a hospital overnight with pain after the implant.This also outlined the implant site, but was not the incision itself.Their hcp said it may have been from implant tape or film.This issue has since resolved.Patient stated that the itching seems to be better after they'd turned stimulation off.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6034243
• MDR Text Key: 57640117
• Report Number: 3004209178-2016-21910
• Device Sequence Number: 1
• Product Code: LGW
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2016
• Date Device Manufactured: 07/20/2016
• 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): Hospitalization
• Patient Age: 60 YR