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

Model Number 97715

Device Problems Overheating of Device (1437); Battery Problem (2885); Charging Problem (2892)

Patient Problems Burn(s) (1757); Burning Sensation (2146); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient was told they needed to charge their implant battery because the implant battery was depleted.They tried to charge their implant for an hour and saw nothing happening.Then they waited another hour and started to feel a burning sensation from the external equipment.They said they were physically burned but there was no mark.They attempted to charge their implant again after this and the same thing happened.The patient was burnt twice but no marks were left on the skin.The recharger was heating while charging and the implant wasn't taking a charge.

Manufacturer Narrative

H3: product id 97755 lot# serial# (b)(6); was returned for product analysis; product was scrapped after failing at plexus and bench testing.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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

Additional information was received.The patient (pt) stated the issue was resolved.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13258940
• MDR Text Key: 286647222
• Report Number: 3004209178-2022-00668
• 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: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 01/14/2022
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2020
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Weight: 75 KG