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

Model Number 97712

Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fall (1848); Fever (1858); Unspecified Infection (1930); Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Discomfort (2330); Complaint, Ill-Defined (2331); Reaction (2414); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturer¿s representative (rep) regarding a patient with an implantable neurostimulator (ins) for failed back surgery syndrome and non-malignant pain.It was reported the patient informed a rep at a normal follow up visit that their nutritionist told them the ¿foreign object in their back was unhealthy and it should be removed.¿ the patient also stated it never was therapeutic, and they have multiple health issues on top of their pain.The healthcare professional (hcp) was going to explant.The surgery was planned, but had not yet been scheduled.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that they were very uncomfortable, unable to adjust unit to meet their needs.Right leg very numb, which in turn caused them to fall.The site where the battery pack was placed made it very uncomfortable to wear pants.Constant pain, burning, very uncomfortable.Charging the unit made this worse.Patient had the implant removed on (b)(6) 2018.Manufacturer reps were not helpful in finding new adjustments, the uncomfortableness and pain were unbearable.No further complications were reported/anticipated.

Manufacturer Narrative

Corrected to both an adverse and product problem.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Information was received from a consumer.It was reported that the neurostimulator (ins) had not worked since implanted.Patient stated they saw healthcare provider back on (b)(6) and healthcare provider agreed to remove ins.Patient stated they had insurance approval for ins to be removed by (b)(6).Patient stated healthcare provider (hcp) told patient they had ins removal set up for (b)(6).Patient stated they can't wait that long and inquired for healthcare provider listings.Patient further clarified that they had been falling, having pain and patient had been uncomfortable since ins was implanted.Patient clarified they could only get comfortable on the toilet.Patient stated on time they fell asleep on the toilet and fell off the toilet hitting their head on the corner of the tub.Patient added the ins area around the incision was seriously swollen and red.Patient saw hcp on (b)(6) 2017 for the area being swollen and hcp prescribed patient an antibiotic.Patient stated they went to sleep on the (b)(6) and woke up freezing so they went outside in the sun.Patient stated they had a serious reaction when they went out to the sun.Patient started swelling the next day.Patient stated by sunday their face was swollen so large they could hardly see and open their eyes.Patient stated another time they had a temperature of 104 and went to the er.Patient stated bottles of blood were taken from the patient and tests were done.Patient stated patient was on so many antibiotics and told patient had an infection.Patient stated they did not know what type of infection they had.Caller was redirected to hcp to discuss removal.It was reported that patient's neurostimulator (ins) hasn't worked for her symptoms.Patient stated she was told the ins could take up to 6 months to find the right setting.Patient stated ins has been adjusted 3 times by manufacturer's representatives.Patient was under the impression that they would be able to have access to programs and adjust ins for when patient was sitting, standing, walking, etc.Patient stated they had only been given 3 settings which 2 were the same.Patient stated she should be able to adjust whenever she needed to.Patient stated they discussed settings with rep and healthcare provider.Patient stated they had seen healthcare provider "i don't know how many times" since implant surgery.Caller was redirected to f/u with healthcare provider to discuss programming and settings.

• 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: 7118556
• MDR Text Key: 94891276
• Report Number: 3004209178-2017-26017
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• 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,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2018
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2018
• Date Device Manufactured: 05/12/2017
• 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 Outcome(s): Required Intervention