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

Model Number 97715

Device Problems Energy Output To Patient Tissue Incorrect (1209); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330); Electric Shock (2554)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a representative (rep) and a consumer regarding a patient who was implanted with a neurostimulator (ins) for spinal pain.It was reported that the patient was experiencing stimulation sensation with the battery turned off and down to 0 milliamps.The rep noted that yesterday they programmed the patient to 85 hertz and 300-350 microseconds.The rep stated that the patient called them and notified them of the stimulation sensation they were experiencing.They reported that when the patient turned the rate and pulse width down to zero it improved the sensations a little bit.No further complications were reported.Follow up was conducted.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient via a manufacturer representative.It was reported that the patient felt an uncomfortable shocking sensation with the ins on and off.It was reported that the sensation would stop if the battery was completely drained of energy.The patient tried different programs and rates and there was no difference.The patient wanted to have the device removed.No further complications 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 manufacturer representative (rep).It was reported that the cause of the issue was not determined.The rep reprogrammed the rate and electrodes.It was unknown if the issue was resolved.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacture representative (rep).It was reported that the device was explanted.No further complications were reported.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative (rep).It was reported that the rep believed the explant date was (b)(6).The device was returned for analysis.No further complications were reported.

Manufacturer Narrative

Analysis of the implantable neurostimulator (b)(4) found no anomaly.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: 7405189
• MDR Text Key: 104749512
• Report Number: 3004209178-2018-06710
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/13/2018

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: 02/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 04/06/2018
• Supplement Dates Manufacturer Received: 05/16/2018; 05/21/2018; 06/01/2018; 06/05/2018; 09/10/2018
• Supplement Dates FDA Received: 05/21/2018; 06/01/2018; 06/06/2018; 06/14/2018; 09/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2018
• 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: 46 YR