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

Model Number 97715

Device Problems Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Electric Shock (2554)

Event Date 05/01/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3998cws, lot# n26491, product type: lead.Other relevant device(s) are: product id: 3998cws, serial/lot #: (b)(4), ubd: 24-mar-2007, udi#: (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 receiving unknown drug via an implantable pump for non-malignant pain.It was reported that pt asked if the leads could ever move where they would cause pinching or shocking sensation.Patient services (pss) asked if pt had been experiencing that, pt said they think they felt a little shock, but mainly pinching and hurting.Pt clarified the first week of may they were at the beach and the last night they were there they were in extreme pain (pt said they think it was because they were bending over picking up seashells).Pt then said they went home and were fine for a while,but then in the past few weeks when it would get late into the night, pt reported the middle of their back and right underneath their chest area would hurt so bad.Pt said they were afraid their leads had moved.Pss asked, pt did not experience any falls.The patient was redirected to their healthcare provider (hcp) to further address the issue.Pss reviewed role of rep and redirected to hcp to request rep meet with pt and to have hcp check on leads/symptoms.Pt said they were already going to call their hcp after calling patient services.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12050133
• MDR Text Key: 266708714
• Report Number: 3004209178-2021-09816
• 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
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2021
• Date Device Manufactured: 02/08/2021
• 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: 55 YR