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

Model Number 97714

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Staphylococcus Aureus (2058); Swelling (2091); Impaired Healing (2378); Skin Inflammation (2443); Fluid Discharge (2686)

Event Date 06/26/2017

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 friend/family member of a patient with an implantable neurostimulator (ins) for the treatment of spinal pain.It was reported that incision was slow to heal at the area at the base of the spine after the implant surgery on (b)(6) 2017.It was reported that the surgeon put glue on it.It was reported that the patient had an infection on the lower spine at the incision starting on (b)(6) 2017.The patient¿s spouse noticed a red ball like a blister on the outside of the wound.The patient applied a cool pack and the swelling went down the next day.The patient had blood tests and was prescribed an antibiotic sulfamethoxazole-tmp ds tablets.It was also reported that the patient¿s sedimentation rate was high at 110.No further complications are anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from the patient's family member reported that the patient's device was explanted on (b)(6) 2017.A culture that had been performed had determined it to be a staph infection.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider (hcp).The hcp reported that the patient presented with wound drainage and dehiscence.The hcp noted that there was concern for infection at the stimulator (ins) site.The ins and leads were removed on (b)(6) 2017.No further complications were reported.

• 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: 6841407
• MDR Text Key: 84637766
• Report Number: 3004209178-2017-18683
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2019
• Date Device Manufactured: 05/18/2017
• 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: 90 YR
• Patient Weight: 79