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

Model Number 97715

Device Problems Delayed Charge Time (2586); Battery Problem (2885); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

Product event summary: investigation summary - it was reported that the patient¿s device was not working properly.As the event was reportable to a regulatory authority and indicated a possible failure of a device, labeling, or packaging to meet any of its specifications, an investigation was required.Additional information was required to determine the cause of the event.The patient was contacted to clarify the report that the device was not working, as well as to investigate the cause of the issue, steps taken to resolve the issue, and if it had been resolved.As the device was still in use at the time this investigation was completed, no analysis could be performed.There was no indication that the event was related to a possible manufacturing issue, so a device history record review was not performed.The investigation determined that there was insufficient information to determine the cause of the event.The root cause of the device not working properly was not reported to the manufacturer, and was unable to be obtained through follow-up requests.Should additional information become available at a later date, the investigation will be re-opened and updated accordingly.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient.It was reported that the patient¿s device was not working properly.No patient symptoms were reported and there were no complications.Indication for use is spinal pain.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information from the consumer regarding the patient with an implantable neurostimulator (ins) on september 24th reported the patient first started experiencing the device not working properly in (b)(6) 2018.The patient stated the circumstances that led to the issue of the device not working properly was they were traveling to michigan and the battery died completely.The patient stated the steps taken to resolve the device not working properly was they talked to the manufacturer, their husband got the battery out and put it back in.The patient noted they it took a while to recharge but, it did they had not had a problem since then and the issue had been resolved.Information was received from a healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported battery slow to recharge after the subject left the stimulator on till the battery died.Additional information was received from a healthcare professional (hcp) via a manufacturer representative (rep) on october 4th.The rep reported the hcp did not specify if any actions were taken.The rep stated the hcp data did not specify the cause of the slow ins recharging.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the battery was slow to recharge due to user error.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: 7736721
• MDR Text Key: 116262685
• Report Number: 3004209178-2018-17084
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 09/24/2018; 07/19/2019
• Supplement Dates FDA Received: 10/02/2018; 10/10/2018; 07/30/2019
• Date Device Manufactured: 06/03/2018
• 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 Age: 74 YR
• Patient Weight: 100