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

Model Number 97715

Device Problems Intermittent Continuity (1121); High impedance (1291)

Patient Problems Headache (1880); Muscle Spasm(s) (1966); Neurological Deficit/Dysfunction (1982); Seizures (2063); Dysphasia (2195); Complaint, Ill-Defined (2331); Neck Stiffness (2434)

Event Date 01/29/2019

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 manufacturing representative (rep) regarding a patient implanted or non-malignant pain.The rep reported that the patient called them and stated that over the past couple of weeks they were getting a surge of stimulation that was causing a spasm in their neck, which felt like it made them pull their neck.It was noted that this was intermittent and would come and go.The rep stated that everything was fine on the day of the patient¿s implantable neurostimulator (ins) replacement surgery.However, on the day of the report, contacts were showing orange (3-6) with impedances greater than 10,000 ohms.They noted that all other values were 640-840 ohms.The rep mentioned that the patient¿s pulling in their neck was not occurring during the impedance check.They stated that the active therapy program does not use electrodes 3-6; they are programmed with -0 -1 +8 +9 +7 80hz 300us 2.0ma.The patient did not report a fall.After the patient left the appointment with the rep, they called them back because they thought they were having a seizure.The patient was experiencing facial droop, difficulty talking, and their right arm felt heavy.The change in symptoms was considered sudden.Technical services reviewed the possibility of turning the device off.The rep stated that when the device has been turned off in the past, things get really bad for the patient.The rep noted that they would like to talk to the patient about potentially turning their c-spine system off because they can tolerate that system being off.The rep inquired if anything else related to the device could be checked.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative (rep) 2019-02-18.It was reported the rep saw patient to provide programming to try some higher frequencies.She was at 80 hz and, per her surgeon, they bumped her up to 160 hz.The rep met with her surgeon who indicated patient¿s complaints of spasms in her neck and surges of stim are not new and that she has reported these issues to him for quite some time.Further, he indicated that the high impedance issues were not a new finding and had been there for quite some time.According to the patient, she did not experience a seizure or stroke based on normal eeg findings.She indicated the symptoms she was experiencing were related to a severe migraine headache.As far as the high impedance issue, they were not using the effected contacts in current programming.It is believed that the issue is resolved, as the rep has had no further complaints from the patient.The patient¿s weight was unknown.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was reported that the rep called back to report the problem has gotten worse and is more frequent.The problem occurs about 4 days per week and is constantly occurring throughout the day.The patient feels pulling up the back of their neck.It pull her neck back which is triggering migraines.The same 4 contacts are still high impedances.The doctor is going to meet with the patient to discuss lead revision.No further information was reported.

Manufacturer Narrative

Product id: 3708120, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2019, product type: extension; product id: 3708120, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2019, product type: extension; product id: 39286-65, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2019, product type: lead; product id: 3550-39, lot# unknown, product type: accessory.Analysis of the lead (39286-65 sn (b)(4)) showed #3, #4, #5, and #6 conductors are broken 11.7 cm from the distal end.Codes were initially applied to the ins, but transferred to lead following analysis results.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id: 3708120, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2019, product type: extension; product id: 3708120, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2019, product type: extension; product id: 39286-65, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2019, product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer representative (rep) 2019-05-30.It was reported that the patient had lead revision (b)(6) 2019.The healthcare provider (hcp) replaced the lead and removed 2 extensions.The rep will send the lead and extension for analysis.The patient¿s impedance issue was resolved.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received 2019-04-22.The cause of the ¿pulling¿ sensation was not determined.Re-programming was tried to see if this would resolve the issue.It is unknown if this resolved the issue.If programming did not make a difference, the rep¿s understanding that the hcp will schedule this patient for a lead revision/replacement.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: 8348268
• MDR Text Key: 136487586
• Report Number: 3004209178-2019-03439
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2018
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 43 YR