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

Model Number 97714

Device Problem Energy Output Problem (1431)

Patient Problems Undesired Nerve Stimulation (1980); Sleep Dysfunction (2517)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 2020-03-09 (b)(4) (con): it was reported that the patient had device reprogramming as they hadn't been using it prior due to having trouble sleeping.They felt even when off during sleep and in minimizing how long therapy was on, they still "felt like" the stimulation was on.They mentioned the healthcare provider (hcp) offered the solution of replacing the implantable neurostimulator (ins), however the patient stated they did not want to do this.Additional information was reported that the patient feels like the device is still on although it has definitely been turned off.The patient's trouble sleeping was not resolved and no other actions have been planned.No further information was reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient clarifying the report ¿if felt like the stimulation was on¿.They stated that they were trying to report that the unit was definitely off but that it gave the sensation like it was still on.It was reported that their troubles sleeping did not resolve following the adjustment.The patient stated for this and other problems they just don¿t use the implant very often.The patient weighed (b)(6) pounds at the time of the event.No further complications were reported/anticipated.

Manufacturer Narrative

Corrections: should have been marked: 2020-04-16 in the previous supplemental regulatory report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• 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: 9921917
• MDR Text Key: 186345988
• Report Number: 3004209178-2020-06671
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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,Followup,Followup
• Report Date: 04/29/2020

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: 04/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 03/16/2020; 04/16/2020
• Supplement Dates FDA Received: 04/24/2020; 04/29/2020
• Date Device Manufactured: 05/23/2014
• 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 Weight: 102