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

Model Number 97713

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

Patient Problems Wound Dehiscence (1154); Erythema (1840); Unspecified Infection (1930); Pain (1994); Discomfort (2330); Skin Inflammation (2443); Alteration In Body Temperature (2682)

Event Date 04/22/2018

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 via a manufacturer representative regarding a patient who was implanted with a neurostimulator for spinal pain.It was reported that the patient had redness, tenderness, and warm to the touch at the generator pocket incision.The discomfort was noticed on (b)(6) 2018.There were no known environmental factors.The patient did not have a fever but was instructed to see a health care provider (hcp) regarding possible infection.The appointment was scheduled for the day of the report ((b)(6) 2018).There were no interventions taken at the time of the report.It was unknown if the issue resolved.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 manufacturer representative (rep) reporting that the patient was seen by their practitioner, however, they did not have any further information regarding their prognosis as the patient nor the physician had called back with any update.It was reported that this was all the information the rep had at this time.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 received from the patient indicated that the physician looked at their implant site, and it felt some heat from the area.The physician assumed the site was infected, and the patient was given antibiotics for 10 days to resolve the issue.No further complications were 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 patient via the manufacture representative reported that they had 2 dime sized blisters at the incision site which burst open at were causing pain.It was noted that the stimulation and recharging were both functional.The patient was suppose to meet with their hcp within the next few of weeks to address the issue.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 manufacturer representative (rep) 2019-05-13.It was reported that the patient was seeing a new pain management physician because she had recently been treated for an infection at her battery site as well as an area along her lead in the middle of her back.She was treated with two rounds of antibiotic therapy approximately one month ago.She noticed at this time a small opening above her ipg.Patient saw pain management physician yesterday and was referred to neurosurgery to potentially have device removed.No further complications were reported/anticipated.

• 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: 7466371
• MDR Text Key: 106673236
• Report Number: 3004209178-2018-09420
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109490
• UDI-Public: 00643169109490
• 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,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2018
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2019
• Date Device Manufactured: 03/03/2017
• 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: 61 YR
• Patient Weight: 95