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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); Unintended Collision (1429)

Patient Problems Hemorrhage/Bleeding (1888); Scar Tissue (2060); Therapeutic Effects, Unexpected (2099)

Event Date 11/05/2019

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 patient who was implanted with a neurostimulator for non-malignant pain.It was reported that the patient fell on her side three or four days after the implantable neurostimulator (ins) was implanted on (b)(6) 2019 noting that her incision ¿bled the tiniest bit of blood.It cracked the edge of the scab.¿ the patient stated that she has been noticing her stimulation kept turning off randomly and going to 0.0 ma.The patient couldn¿t feel the ¿buzzing¿ when she checked her stimulation settings before bed.The patient added that she could feel the difference when the stim was set to 0.0ma.A log was kept when the patient¿s stimulation would turn itself down to 0.0ma, noting that it occurred on the following dates: (b)(6) 2019, (b)(6) 2019, (b)(6) 2019, (b)(6) 2019, and (b)(6)2019.It was noted that the stimulation hadn¿t turned itself down to 0.0 ma in two days.This issue was not happening in specific positions or different times of the day and the patient confirmed that adaptive stimulation was turned on for programs 1 and 2 which they increased to 3.0 ma.The patient was advised to turn adaptive stim off and monitor if the issue persisted.In the end, the patient was redirected to follow-up with their healthcare professional (hcp) to have ins checked but the patient stated that hcp told them that the ins would be okay.There were no further complications reported or 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: 9527632
• MDR Text Key: 173095267
• Report Number: 3004209178-2019-24496
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2019
• Date Device Manufactured: 06/10/2019
• 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 Age: 52 YR