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

Model Number 97714

Device Problems Energy Output To Patient Tissue Incorrect (1209); Battery Problem (2885); Charging Problem (2892)

Patient Problems Nerve Damage (1979); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 02/15/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator.It was reported that the patient had an issue and was hoping that it is not a serious problem.It [implantable neurostimulator] has been run down or dead for a couple of weeks, and when the charge was completely gone, the patient noticed that from his waist down to both feet, still felt like it was still running.The patient compared this to as he is standing on something that¿s vibrating and it never stops.There were no further complications reported or anticipated.

Event Description

The patient feels it all the time.The patient had asked their pain management physician if there was a chance that they have some kind of nerve damage, but the health care provider said that she could have, but didn¿t¿ actually come out and say that is what is causing the symptom.The patient had decided not to try and recharge it [implantable neurostimulator].

Event Description

Additional information was received from a patient on 2017-may-14.The patient reported that they have an intermittent charging problem but they also believe that they have suffered nerve damage.They actually let it run down completely simply because they get little relief for the trouble of using it but they have pain in their spine where the leadsor paddles or whatever they are called are implanted in their spine.The pain feels like someone punched their spine and the pain is continuous.Their main concern is that the last time they used it and let it run down, it felt like it was still running so they decided not to charge it and just run it completely dead but the sensation or vibrating feeling has never stopped and it¿s been a couple months.The last time they had problems someone got right back to them right away.They contacted their manufacture representative (rep) with their concerns like they have done in the past but they haven't heard anything from their rep either.They haven't contacted their healthcare professional (hcp).The patient is very concerned that something serious has happened and they may have something very serious happening.The patient thinks that it needs to be removed since it really has never helped my pain and they are having even more problems with it.No further complications were 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 on july 03, 2017.It was reported that no actions were taken to resolve the issues, they felt a vibration as if the implantable neurostimulator (ins) was still on and its¿ been occurring for about three months.The patient also reported that they would have the ins removed as soon as they could, they never had sciatica pain, the device did not help and they also felt pain where the electrodes were located.The issues were not resolved at the time of the report.There were no further complications reported or anticipated.

Manufacturer Narrative

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: 6439360
• MDR Text Key: 71047221
• Report Number: 3004209178-2017-06487
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/03/2017
• Date Device Manufactured: 09/08/2014
• 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 Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 136