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); Patient Device Interaction Problem (4001)

Patient Problems Bruise/Contusion (1754); Unspecified Infection (1930); Pain (1994); Skin Erosion (2075)

Event Date 10/26/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.The patient reported that it started turning in the pocket and was rubbing and built up a ridge and broke through the skin.The patient reported that surgery was set for (b)(6) 2019.No further complications were reported.

Manufacturer Narrative

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) for failed back surgery syndrome and spinal pain.The patient reported that her ins was sticking out of her skin and was causing pain.The patient reported that this was the left ins and this seemed as though the battery had slipped out and pressing up against the top layer of skin.The patient reported that it was hitting skin and hurts.The patient reported that her husband said the site was black and blue, looked like it was breaking through the skin.The patient reported that she bumped into a doorway and after that its all started to do this.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient via a manufacturer representative (rep) reporting that the patient complained their battery seemed to be protruding and made an appointment with their doctor on (b)(6) 2019 where they discovered that part of the battery was in fact protruding from the skin.An infection was reported.The cause of the issue was unknown.The doctor removed the battery on (b)(6) 2019 and would be scheduling a replacement.The issue was not resolved at the time of the report.The customer discarded the explanted battery, so it will not be returned for analysis.The rep indicated that they would obtain additional information from the healthcare provider (hcp) on 2020-02-22.No further complications were reported/anticipated.

Manufacturer Narrative

Product id: 3778-60, serial# (b)(4), implanted: (b)(6) 2009, product type: lead; product id: 3778-60, serial# (b)(4), implanted: (b)(6) 2009, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative (rep).It was reported that one of the leads migrated down.The device was able to stimulate the areas needed with the other lead, so no other further action was needed at this 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: 9398570
• MDR Text Key: 177899904
• Report Number: 3004209178-2019-22901
• 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,Followup,Followup,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2020
• Date Device Manufactured: 02/05/2018
• 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: 70 YR
• Patient Weight: 77