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

Model Number 97713

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930); Pain (1994); Swelling (2091); Complaint, Ill-Defined (2331); Skin Inflammation (2443); Fluid Discharge (2686)

Event Date 04/01/2017

Event Type  Injury  

Manufacturer Narrative

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 consumer about a patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient had an abscess on the implant, which was discovered in the emergency room on (b)(6) 2017 and it was scheduled to be removed on (b)(6) 2017.The patient requested to have a manufacturing representative present at the explant.The patient was redirected to follow-up with their healthcare provider to address the abscess and to coordinate with a rep.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 the patient.It was reported that the patient had lost a lot of weight and the stimulator was sticking out of their body.This started about 6 months ago.It got caught on something and they got a blood blister mid-april.It was reported the implant site got infected in april.It was the size of a saucer and it abscessed (b)(6) 2017.The patient went to the emergency room and they were started on antibiotics for 10 days.Symptoms reported included swelling, drainage, and pain.The patient reported that (b)(6) 2017, she called her healthcare provider because the implant site was oozing green stuff and it got on their underwear and gown.The patient returned to the emergency room because it was severely infected and they were given a vancomycin 1000mg iv injection.The patient also mentioned having pain at the implant site, which started in (b)(6) 2017 and was given pain medicine.The patient said that friday, (b)(6) , they could not do an mri because they did not have the controller.A ct scan was performed and the patient was on iv antibiotics for 3 days.The ct found the infection was all the way down to the bone and the size of a saucer.They were trying to get a surgeon to take it out.

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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 6593238
• MDR Text Key: 76018586
• Report Number: 3004209178-2017-11090
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2014
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2017
• Date Device Manufactured: 09/30/2013
• 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: 56 YR