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

Model Number 97715

Device Problems Unintended Collision (1429); Ambient Noise Problem (2877)

Patient Problem Pain (1994)

Event Date 09/12/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative (rep) on 2018-sep-28.The rep indicated that it was not determined how the fall affected the device.No actions have been taken to resolve the patient.They are using their stimulator for their chronic pain.The patient¿s weight at the time of the event was unknown.This information was confirmed with the physician/account.Additional information was received from the rep on 2018-oct-02 indicating that the patient¿s pain is getting worse.Additional information was received from the rep and a healthcare professional (hcp) on 2018-oct-09.They inquired about removing just the ins but still leaving the lead.Technical services reviewed that since the lead wire is still left in place then there is still a potential for energy to get coupled onto it, thus affecting the patient.No further complications were reported/are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a hcp via a manufacturer representative.It was reported that the patient was complaining of pain in the hip.It was reported that the patient used an exogen ultrasound bone stimulator and turned off the ins due to the ultrasound helping the pain.The patient's hcp decided to remove the patient's ins.Impedances could not be tested as the patient refused to charge because it caused them pain.No further complications are anticipated.

Manufacturer Narrative

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

Event Description

Information was received from a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins) for spinal pain.The patient has pain on their right hip area beginning 2 weeks prior to the report.The caller does not know where the pain is originating from but it was from a fall.The caller reports that the ins is implanted on the right hip area.No further complications were reported/are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a rep who confirmed the information with the hcp.They reported the ins was explanted on (b)(6) 2018.The ins and two leads were returned for analysis; received in on october 25, 2018.The reason for the explant was due to the pain at the ins site.The patient recovered without sequela.No further complications were reported or anticipated.

Manufacturer Narrative

Analysis of the ins found no anomalies.The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The returned device passed all testing in the laboratory and no anomalies were identified.If information is provided in the future, a supplemental report will be issued.

• 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: 7922762
• MDR Text Key: 123419229
• Report Number: 3004209178-2018-21931
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2017
• 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): Required Intervention
• Patient Age: 68 YR