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

Model Number 97715

Device Problems Malposition of Device (2616); Charging Problem (2892)

Patient Problems Irritation (1941); Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Discomfort (2330); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding an implantable neurostimulator (ins) for the treatment of spinal pain.It was reported that the patient was causing them problems and no one called them from their healthcare provider (hcp).The patient mentioned that they can't charge it, has a bad sensation in their hips and has a burning and ripping sensation in their spine.The patient wanted it removed.The patient stated that there is burning and irritation where the ins and leads are located.The patient stated that it feels like their skin is being ripped off the spin and wants the device taken out.The patient stated that they have never gotten a call from anyone since implant.The patient stated that they got a call every day during the trial.The patient stated that they are unable to charge the device because of the location of it.The patient stated that they can¿t sit fir that long because it is right on the belt line so they have to stand.The patient stated that every time they sit it hurts and burns.The patient stated that their device was implanted on the wrong side.The patient stated that they were sick and in pain and ended ip in the er about a week after the initial implant.The patient stated that they had a ct scan and they couldn't find anything wrong.The patient stated that they ended up at the pain clinic right after, the patient stated that they ended up with a knot that turned into a baseball right over the incision of the spin that still comes and goes, the patient notified the healthcare provider (hcp) regarding the burning and discomfort but they were told to give it time.The patient stated that the device is off and they haven't charged in a few weeks.No further complications were 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: 7573776
• MDR Text Key: 110337085
• Report Number: 3004209178-2018-12731
• 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,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2018
• Date Device Manufactured: 12/20/2017
• 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: 40 YR