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

Model Number 97715

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

Patient Problems Wound Dehiscence (1154); Pain (1994); Staphylococcus Aureus (2058); Discomfort (2330); Fluid Discharge (2686)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977c265, serial# (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2020, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the patient via a manufacturer representative (rep).The patient was implanted with a neurostimulator for unknown indications.It was reported that the patient experienced ongoing implantable neurostimulator (ins) battery pain, discomfort at the battery site, and the pain in the patient¿s back increased dramatically, so she went to see her surgeon to further discuss the pain.On the morning of the appointment, the patient¿s battery incision opened and began to drain green drainage.Cultures of the wound were taken and according to the patient, staph was found in the patient¿s wound.There were no external factors identified.To decrease the battery site pain the patient placed gauze over the site and used an elastic band to help the battery not to protrude.The patient also mentioned that she placed a heating pad above where the battery was placed.In the end, the ins and the lead were explanted, the patient was still recovering from the explant and had a follow-up appointment scheduled for (b)(6) 2020.There were no further complications reported or anticipated.

• Brand Name: INTELLIS
• 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: 9645793
• MDR Text Key: 185519945
• Report Number: 3004209178-2020-02158
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Date Device Manufactured: 06/22/2019
• 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: 64 YR
• Patient Weight: 82