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

Model Number 97702

Device Problems Migration or Expulsion of Device (1395); Unstable (1667); Device Operates Differently Than Expected (2913)

Patient Problems Bruise/Contusion (1754); Unspecified Infection (1930); Irritation (1941); Pain (1994); Pocket Erosion (2013); Burning Sensation (2146); Anxiety (2328); Discomfort (2330); Complaint, Ill-Defined (2331); Deformity/ Disfigurement (2360); Skin Inflammation (2443); Cognitive Changes (2551); Skin Inflammation/ Irritation (4545); Insufficient Information (4580)

Event Date 12/18/2017

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 consumer regarding a patient who was implanted with a neurostimulator (ins) for non-malignant pain.Information was reported that the patient wanted to know if there is a size difference between his old and new batteries.It was reviewed with the patient that the batteries are the same size.The patient indicated the reason he was asking is because he is having a problem with the new battery, it is rubbing a hole or a blister or something on the inside and if you touch it, it burns similar to how a blister would.No further complications were reported.No additional patient symptoms 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 on 2018-mar-27.The patient stated that they are having their implantable neurostimulator (ins) moved because it is ¿killing them¿.No further complications were reported/are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient reporting that they had a new battery put in (b)(6) 2017.The patient stated the device was irritating under the skin and felt like a blister since it was implanted ((b)(6) 2017).The patient stated that six to eight weeks ago (2018) the doctor moved the device and now it was sideways (beginning 6-8 weeks ago 2018).It was reported that the patient called because they were looking for a surgeon in the area.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer regarding the patient.It was reported that the patient had the whole system removed due to infection in (b)(6) 2018.There were no further complications reported or anticipated.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received stating that hcp surgically replaced the implant, using the same pocket in pt's left abdominal wall that had preciously housed the prior implant.In doing so, hcp did not affix the implant to the fascial tissue surrounding the abdominal muscle, leaving the implant floating freely in the cavity where it had been placed.The new implant oved freely in the cavity as it was smaller than the previous implant, causing pain and discomfort.On (b)(6) 2018 pt follow-up treatment with hcp and complained he was experiencing discomfort from the positioning of the battery.It was noted that pocket was loose and surgical re-positioning of the battery was recommended.On (b)(6) 2018 hcp again undertook to surgically replace and/or reposition the stimulator, creating a new cavity for te placement of the same.Again, hcp did not affix the stimulator to any fascial tissue surrounding the abdominal muscle, leaving battery floating freely where it has placed.On (b)(6) 2018, pt reported to er noting that the implant had rubbed through his skin and was outwardly visible.On (b)(6), 2018, pt came under the care and treatment of another hcp who recommended removal of the entire scs.Hcp performed surgery on (b)(6), 2018.It was not until june 7, 2019 when stimulator could be surgically re-implanted with the implant being implanted elsewhere on pt's body.As a direct and proximate result, pt sustained infection, skin erosion, increased back and leg pain, increased healing time required to recover from the improper implantation of the stimulator, increased healing time to recover from the infection caused by the additional surgeries required to correct improper implantation of the battery.Nervousness, emotional trauma and/or anxiety, bruises, contusions and other injuries in or about nerves, muscles, bones, tendons, ligaments, tissues and vessels of the body, other injuries.Additionally, pt has suffered the following damages, some of which may be of permanent in nature: disfigurement, great pain, suffering, inconvenience, embarrassment, mental anguish and emotional and psychological traumas, inability to enjoy various pleasures of life that were previously enjoyed, loss and impairment of general health, strength and vitality.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 7297588
• MDR Text Key: 101159681
• Report Number: 3004209178-2018-03995
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• 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: Other
• Reporter Occupation: Patient
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/02/2022

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: 10/14/2018
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 02/26/2018
• Supplement Dates Manufacturer Received: 03/27/2018; 05/25/2018; 09/03/2019; 01/11/2022
• Supplement Dates FDA Received: 03/30/2018; 05/30/2018; 09/05/2019; 02/02/2022
• Date Device Manufactured: 04/21/2017
• 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
• Patient Age: 65 YR
• Patient Sex: Male