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

Model Number 97714

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

Patient Problems Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Seroma (2069); Post Operative Wound Infection (2446)

Event Date 05/28/2014

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 977a275, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id 977a275, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.(b)(4).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

Information was received from a manufacturer representative and a patient who was implanted with a neurostimulator for spinal pain.It was reported that after implant of the scs system on (b)(6) 2014, the patient woke up and had blood all over their bedding from the implant site.The patient reported a seroma post implant.The health care professional (hcp) tried to ¿clean out¿ the infection at the implantable neurostimulator (ins) and lead sites but ended up removing the entire system and told the patient that they would try to implant later.The patient was scheduled for having the pain stimulator re-implanted on (b)(6) 2016.

Event Description

Additional information received from the consumer reported that prior to having their system removed shortly after implant they had a seroma that became infected (they were unsure if it was at the lead or implantable neurostimulator site), so they were hospitalized for weeks and received iv antibiotics.The consumer had two surgeries to try and drain/clean it out, but they were unsuccessful.As a result the complete system was removed, but then the consumer contracted c.Diff.

Manufacturer Narrative

Product event summary # (b)(4): evaluation determined that there was no allegation of a device failure, but standard investigation is needed because the event was determined to be reportable to a regulatory body.The source information indicates a potential relationship between the adverse event(s) reported and the device therapy.Assessment determined that there is not an existing formal investigation for the issue identified in this event.However, a formal investigation is not needed because the issue identified in this event is a known inherent risk as disclosed in product labeling, and additional investigation is not needed.Supporting event information used to determine the issue was a known event includes the reports that after implant the patient had a seroma and infection that the hcp tried to clean out at the ins and lead sites which led to a system explant.(b)(4): evaluation determined that there was no allegation of a device failure, but standard investigation is needed because the event was determined to be reportable to a regulatory body.The source information indicates a potential relationship between the adverse event(s) reported and the device therapy.Assessment determined that there is not an existing formal investigation for the issue identified in this event.However, a formal investigation is not needed because the issue identified in this event is a known inherent risk as disclosed in product labeling, and additional investigation is not needed.Supporting event information used to determine the issue was a known event includes the report that the hcp tried to clean out infection at the ins and lead site but ended up explanting the system.Concomitant products: product id: 977a275, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 977a275, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.

Event Description

(b)(4).Information was received from a manufacturer representative and a patient who was implanted with a neurostimulator for spinal pain.It was reported that after implant of the scs system on (b)(6) 2014, the patient woke up and had blood all over their bedding from the implant site.The patient reported a seroma post implant.The health care professional (hcp) tried to ¿clean out¿ the infection at the implantable neurostimulator (ins) and lead sites but ended up removing the entire system and told the patient that they would try to implant later.The patient was scheduled for having the pain stimulator re-implanted on (b)(6) 2016.(b)(4): additional information received from the consumer reported that prior to having their system removed shortly after implant they had a seroma that became infected (they were unsure if it was at the lead or implantable neurostimulator site), so they were hospitalized for weeks and received iv antibiotics.The consumer had two surgeries to try and drain/clean it out, but they were unsuccessful.As a result the complete system was removed, but then the consumer contracted c.Diff.Unrelated paralyzed event captured in pe (b)(4).(b)(4): additional information was received from the patient reported that they got infected due to a seroma.The patient had 4 surgeries to clean the site out but, finally, the healthcare professional (hcp) removed the ins.It was noted that the ins was just implanted for 4 weeks.[omitted information related to pe (b)(4): pain at ins].

Manufacturer Narrative

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

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.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 from the patient reported that they had their first implant but after 3 weeks it had to be taken out because the pt had gotten an infection.Pt said they had to be on antibiotics for 3-6 months and didn't get it put back in for 6-7 months later.Pt did not remember when this event happened.Asked if it was the implant from 2014 and pt said they don't remember but that it might have been.Pt said they had a surgery in 2011 but might have been 3 years before the ins was put in, pt was giving confusing information it was unclear if the first surgery in 2011 was the back surgery that caused the nerve pain for why the scs was implanted.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 5784137
• MDR Text Key: 49232504
• Report Number: 3004209178-2016-13965
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/31/2021

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: 02/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2016
• Initial Date FDA Received: 07/11/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 11/21/2016; 03/30/2021
• Supplement Dates FDA Received: 08/30/2016; 12/16/2016; 09/24/2017; 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR