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

Model Number 97715

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Undesired Nerve Stimulation (1980); Seizures (2063); Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a275, serial# (b)(4), implanted: (b)(6) 2018, product type: lead.Product id: 977a275, serial# (b)(4), implanted: (b)(6) 2018, product type: lead.Information references the main component of the system.Other relevant device(s) are: product id: 977a275, serial/lot #: (b)(4), ubd: (b)(6) 2020, udi#: (b)(4); product id: 977a275, serial/lot #: (b)(4), ubd: (b)(6) 2021, udi#: (b)(4).Other: seizure-like episodes.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient reported their ¿wires¿ were ¿pushing on motor nerves of spine and causing seizure-like episodes.¿ the patient noted that a manufacturer representative had told them their ¿sx were in [their] head when [they] complained¿ and that an ¿x-ray would have shown wires moved.¿ no further event information was reported; no further complications were reported or 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: 7593703
• MDR Text Key: 110844236
• Report Number: 3004209178-2018-13260
• 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: Other
• Type of Report: Initial
• Report Date: 06/12/2018

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: 12/14/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/12/2018
• Date Device Manufactured: 12/22/2017
• 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): Other