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

Model Number 97715

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fainting (1847); High Blood Pressure/ Hypertension (1908); Pain (1994); Dizziness (2194); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient said the ins was working great but now the patient's pain had returned.The patient said she met with the manufacturer representative (rep) for a routine adjustment the week prior to the report and after the adjustment the patient was feeling great; the patient said now they can't seem to get the stimulation right to provide relief and the patient said they usually had the stimulation running low.The patient increased on both groups a and b and said that group a and b are for the right and left side.The patient stated that the right side was at 3.7 and the left side was at 3.5 but before the rep made an adjustment the patient was at 6.0.The patient said that if they increased to 6.0 now their "heart feels like it's going to jump out of my chest"; the patient said from increasing stimulation they got light headed like they were ready to faint, their blood pressure was a little high and they were uncomfortable/had uncomfortable stimulation.The patient reported that after the attempted adjustments they were still not getting relief in the right side but the left side was not painful.The patient said they still had stitches and inquired if taking a shower would affect the ins.The patient said most of the pain was in their "lower right back", glute area, down the side and outside of the calf.The patient was directed to their healthcare professional and it was reviewed that patient may need another adjustment.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: 7296689
• MDR Text Key: 101243179
• Report Number: 3004209178-2018-03958
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2018
• Date Device Manufactured: 01/21/2018
• 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: 50 YR