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

Model Number 97716

Device Problem Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Date 11/10/2019

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 patient regarding their implantable neurostimulator (ins) for non-malignant pain.It was reported that patient has been having more pain than usual in her neck and legs toward the end of last week.Patient's been in a huge amount of pain and feels like she needs to have another surgery or something because her neck is killing her lately.Patient thinks that maybe the pain in her neck "spilled over" to her legs.At one point the ins was helping with her neck.Patient stated that she took out the li-battery and put the aa batteries in its place, thinking this would resolve the issue with her pain.Patient increased intensity to almost 10 on group b, decreased it at night, then increased again today to 9.8.However, she is having trouble walking and is thinking about decreasing the intensity.Patient thinks she is having trouble walking because of the problem she is having with her neck.Patient added that she's also changed groups, noting that group b works the best; stated her hcp put her on oxycodone last week, and before that she was in the hospital because of the pain in her neck and legs.Patient's hcp did a trigger point injection last week; the trigger point helped for a time but now is no longer effective.Patient mentioned that she went in for an mri of her neck this morning.Pss had patient put the li-battery back in and she confirmed controller battery is at 100% and ins at 40%.Patient confirmed ins is on and can feel stimulation in her leg.Patient mentioned that she had called mdt reps in the past because she was "so sick of the remote." patient clarified and stated that she is homebound and was never educated on the controller and had to self-educate herself using the manuals.No allegation was made against the controller in this statement.Later, the rep stated that patient has a bit of a memory issue and they will contact them.No further complications were reported.

Manufacturer Narrative

The hospitalization no longer applies to this event.Method, conclusion, and result codes no longer apply to this event.Patient code (b)(4) no longer applies to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative (rep).It was reported the cause was not determined.The rep educated the patient again on keeping the intensity level at a comfortable level.The rep also confirmed the therapy was in place to relieve back pain and not neck pain or pain associated with constipation.The patient was temporarily turning the therapy off and checking back in with the rep so she can get a baseline.No further complications were reported.

• 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: 9384302
• MDR Text Key: 168772353
• Report Number: 3004209178-2019-22755
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781740
• UDI-Public: 00643169781740
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: 97716
• Device Catalogue Number: 97716
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2019
• Date Device Manufactured: 04/07/2019
• 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): Hospitalization
• Patient Age: 73 YR