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

Model Number 97715

Device Problems Overheating of Device (1437); Malposition of Device (2616)

Patient Problems Burn(s) (1757); Discomfort (2330); Complaint, Ill-Defined (2331); Skin Inflammation (2443)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Additional information was reported that the cause of the blistering after recharging was due to the ins being too close to the surface of the patient's skin.The patient doesn't know what was done, but the doctor opened the patient up where their ins was coming through their skin.The patient was not told what was done and was just sent home.No further information was reported.

Manufacturer Narrative

Concomitant medical products: product id: 97755, serial# : (b)(4), product type: recharger.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient had the ins for 1-1.5 years.The patient charged the ins on the wednesday prior to the report and the following day noticed that she got canker sores on top of it, blisters that were popping.The patient could not even touch it because it was so sore.The patient thought the ins was so close to the outer layer of her skin.The patient turned the ins off and had an appointment scheduled with her hcp for (b)(6) 2020.The patient was scared to put the recharger over the ins.It looked like it burned it or something.The patient said she did not put the recharger over bare skin when she last charged adding that she was using adhesive discs that were over her underwear.The patient said she had been using adhesive discs for a long time.No further complications were 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: 9574056
• MDR Text Key: 186462637
• Report Number: 3004209178-2020-00736
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2020
• Date Device Manufactured: 05/30/2018
• 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: 122