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

Model Number 97715

Device Problems Energy Output Problem (1431); Overheating of Device (1437); Delayed Charge Time (2586); Charging Problem (2892)

Patient Problems Burn(s) (1757); Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Therapeutic Response, Decreased (2271); Skin Inflammation (2443); Burn, Thermal (2530)

Event Date 02/29/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97755, serial#: unknown: product type: recharger.Other relevant device(s) are: product id: 97755, serial/lot #: unknown.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).It was reported that a couple of weeks after implant, group a quit working so they had to switch over to b.The patient texted a rep and said they could feel it on the left side and in some of their left leg.The only places they felt stim was one spot on their back and one spot of their thigh.The patient had to keep turning the power up more and more on a.The rep told the patient he was on hd programming and stim should be set below where the patient feels it.The patient had to crank it back up stating they can feel some of it, but it was not like it was.The patient said after turning to b, they had to charge more.They were charging about 2-3 times per day or every 4-5 hours.Charging difficulty gradually got worse, where before switching to b, the patient would charge the ins to 100% in a half hour.The controller would only be down to 80-90%, but it has gotten to a point where it takes almost 2 hours to charge the ins and it was killing the remote.X-rays were trying to be arranged to ensure the leads didn't move, but this has not been done due to covid-19.It was also mentioned that the recharger was getting hot and felt like it was burning.A picture of blistered skin was sent to the rep.The patient was instructed to turn the charging speed down which the patient said didn't help.It was confirmed the blistering was gone now.The recharger heating seemed to be resolved.It was stated that it got to the point where the patient would charge the ins and it gave them pain in their right hip, "like a pain from pressure while charging." 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: 9961906
• MDR Text Key: 187698477
• Report Number: 3004209178-2020-07197
• 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: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2020
• Initial Date FDA Received: 04/15/2020
• Date Device Manufactured: 05/17/2019
• 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: 43 YR