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

Model Number 97715

Device Problem Human-Device Interface Problem (2949)

Patient Problem Pain (1994)

Event Date 11/05/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 977c165, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type lead; product id: 977c165, serial/lot #: (b)(4), ubd: (b)(4) 2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the healthcare provider via manufacturer's representative regarding a patient who was implanted with a neurostimulator for spinal cord stimulation nonmalignant pain.It was reported that the patient was implanted with a paddle lead on (b)(6) but was experiencing extreme abdominal pain.The paddle lead was removed and replaced with a percutaneous leads to see if that resolved the issues.During the replacement surgery the hcp was unable to successfully replace the paddle with a percutaneous leads so he did a full explant.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer's representative.It was reported that there appeared to be some type of obstruction in the patient's anatomy that consistently pushed the leads anterior and would not allow for advancement to the trial location.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep.It was reported that the devices were discarded by the hospital and will not be returned.No further complications were reported/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: 8060035
• MDR Text Key: 126918402
• Report Number: 3004209178-2018-25206
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2018
• Date Device Manufactured: 08/29/2018
• 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: 48 YR