• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97702
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Inflammation (1932); Nausea (1970); Swelling (2091); Vomiting (2144); Chills (2191); Sweating (2444); Pallor (2468)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The healthcare professional (hcp) reported through a manufacturer representative that the patient had experienced inflammation and a ¿possible implantable neurostimulator (ins) infection¿ at the ins site/sutures. The patient was admitted to the hospital and was receiving intravenous antibiotics at the time of report; the issue remained unresolved at that time. A physician who was involved with the patient¿s care reported on 2020-feb-03 that he ¿didn¿t think there was any infection, only inflammation. ¿ the results of a culture attempt remained unknown as of (b)(6) 2020. There were no surgical interventions performed and it was asked, but unknown whether any were planned. A number of external factors were reported that may have led or contributed to the issue: the procedure took a long time, the patient had many comorbidities, and the patient did not attend follow-up appointments for wound checks/suture removal despite multiple options being offered. There were no further complications reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the hcp reported the patient ¿had marked symptoms of infection by the time she came to the clinic. ¿ it was noted the patient had ¿nausea and vomiting, rigors, pale and clammy¿ and ¿there was notable swelling and purulent discharge from the suture site. ¿ the patient was commenced on oral antibiotics by her general practitioner prior to being swabbed for infection, which the hcp ¿believed was why she had a negative swab. ¿ it was noted the patient was admitted to the hospital and commenced on intravenous antibiotics upon reporting with her ¿possible infection. ¿ the patient had since been discharged from the hospital and was ¿sounding much better again¿ according to the hcp. It was noted the patient had a long-term prescription for antibiotics and that the hcp had stressed the significance of taking the entire course. It ¿sounded as though she (the patient) was back on track¿ at the time of follow-up. The hcp noted that she had made several attempts to see the patient for suture removal leading into the new year and again in early(b)(6) 2020, but the patient ¿unfortunately did not attend or follow the advice she was given. ¿ the patient¿s ins was put in an antibiotic pouch at the time of implant, which the hcp stated was ¿what really saved her. ¿ no further complications were reported or anticipated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURESCAN
Type of DeviceSTIMULATOR, 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 Key9671522
MDR Text Key178355077
Report Number3004209178-2020-02617
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/28/2020
Device Model Number97702
Device Catalogue Number97702
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/28/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/05/2020 Patient Sequence Number: 1
-
-