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

Model Number 97715

Device Problems Migration or Expulsion of Device (1395); Overheating of Device (1437); Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problems Inflammation (1932); Irritation (1941); Pain (1994); Increased Sensitivity (2065); Swelling (2091); Burning Sensation (2146)

Event Date 05/25/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received by a manufacturing representative (rep) regarding a patient with an implantable neurostimulator (ins) for non-malignant pain.Information was reported that the rep said the patient's ins was getting hot on saturday ((b)(6) 2019) and the area was inflamed.The patient said the swelling has gone down today.An impedance check showed 700-2500 ohms depending on the electrode referenced.The patient said the issue occurred while he was walking.No accident or trauma.The healthcare provider (hcp) came in the room and examined the patient.He indicated that the patient's pocket site is sensitive to the touch.The hcp also observed that the implant might have moved since it's more midline and the hcp normally doesn¿t implant that close to midline.The hcp is planning on surgery in (b)(6).No further complications were reported.No additional patient symptoms were reported.

Manufacturer Narrative

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

Event Description

Additional information was reported that the patient wanted a manufacturer representative (rep) to check his device.The patient said last may it started to get swollen and he started to have a lot of pain and then it went away.The patient said for the last three weeks it has been painful and swollen.The patient was redirected to follow up with their healthcare provider (hcp).No further complications were reported.No additional patient symptoms were reported.

Manufacturer Narrative

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

Event Description

Additional information was reported that a date has not been set for the surgery and will not be set until the patient's insurance issues are rectified according to the physician.The doctor believes the heat was caused by inflammation from irritation of the device being too midline.He said it may be rubbing or irritating the area.No further information was reported.

• 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: 8650809
• MDR Text Key: 146396927
• Report Number: 3004209178-2019-10468
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2019
• Date Device Manufactured: 10/19/2017
• 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: 35 YR
• Patient Weight: 66