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

Model Number 97702

Device Problem Overheating of Device (1437)

Patient Problems Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Burning Sensation (2146); Malaise (2359); Numbness (2415); Fluid Discharge (2686)

Event Date 06/29/2016

Event Type  Injury  

Event Description

A consumer reported when they had their stitches removed there was "yellowish, bloody, watery fluid stuff" oozing out from the incision site.The healthcare provider (hcp) told the consumer it was the fat that was being heated up by the implant being hot, and they should clean it with saline.The consumer was given levofloxacin 500mg to take once a day for seven days, but they were only able to take it for three days.According to the consumer they almost passed out from the medication because it gave them a flu like sensation and burning and numbness in the arms, legs, and feet.The consumer tried cutting the medication in half to see if cut the symptoms but instead the medication was discontinued and another one was started.According to the consumer the area was improving but there was still a little opening at the incision with a lot of puss and blood on the dressing, but it had improved since removing the insulin pump/sensor.A follow-up appointment was scheduled for (b)(6)2016.

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: 5815550
• MDR Text Key: 50212405
• Report Number: 3004209178-2016-14766
• 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: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2017
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2016
• Date Device Manufactured: 05/03/2016
• 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): Required Intervention
• Patient Age: 62 YR