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 Device Overstimulation of Tissue (1991); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

Continuation of medical devices: product id 97745, serial# (b)(4), product type programmer, patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient (pt) was having problem with her controller.The pt stated that the patient programmer (pp) was on the counter the week prior to the notified date and all of a sudden, the stimulation was going higher and higher.The pt stated that she could not stop the stim until she turned it off.It was mentioned that the pt contacted her manufacturer representative (rep) and was told to contact the manufacturer.The pt stated that she had to shut the stimulation off because it was going out of whack on friday and it was increasing.The pt stated that the numbers went higher on their own and the pt was standing when it occurred.It was stated that the stimulation goes high to where it would start bubbling in her heart and she shut the stim off because it hurt her so badly.It was confirmed that her stimulation was still off and the pt was not feeling any sensation.It was noted that the pt was usually at 19 and the number on the controller was 46.It was suggested that the pt use the pp on the call but the pt refused and stated she tried to charge it when she was charging, the charger went dead.The pt mentioned that once it was charged, the stim went up high and it hurt her.It was mentioned that the rep told the pt to shut the stim off.The pt was asked if they wanted to troubleshoot on the call or with a rep and stated that they were unable to troubleshoot and needed to charge it up.The pt stated she was in the process of charging in the morning and wanted to speak to someone else.The pt called again and repeated the same information.It was stated that the pt got water on the controller and the rep told her to call for a replacement.The pt was transferred to repair and the controller was replaced.The pt called back requesting assistance with the controller.An out of box failure wa s not reported.No symptoms were reported.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: 7664721
• MDR Text Key: 113283159
• Report Number: 3004209178-2018-15095
• 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: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2018
• Date Device Manufactured: 02/06/2018
• 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: 52 YR