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

Model Number 97714

Device Problems Charging Problem (2892); Device Operates Differently Than Expected (2913); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 09/05/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient with an implantable neurostimulator (ins) for spinal pain and chronic low back pain.The patient is having to charge their stimulator every other day.They have not been recently reprogrammed or increased parameters.They might be getting the new ins because their healthcare professional (hcp) told them that it was capable of achieving 1000 hertz and may be able to provide a higher level of pain killing for them.The patient is always open to anything that would give them more pain relief and they want to reduce the amount of medication that they are on.The patient stated that a year prior to the report they hurt themselves and no one has ever really identified what they did and they always thought that it had done something to the implant.They had x-rays that showed nothing was out of place with the device and they had the device checked by a manufacture representative (rep) and that did not show anything out of the ordinary.The patient does not notice any unusual changes in stimulation sensation with changes in body position.The patient stated that since implant they are not getting the highest level of pain relief and they are charging more frequently which has gotten worse in the last month.The patient was redirected to follow up with their healthcare professional (hcp).No further complications were reported/are anticipated.

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 (b)(6) 2018.The patient stated that the cause of the patient having to charge every other day was due to reset charger/device.The changed their implantable neurostimulator (ins) to a different device which has successfully reduced their pain significantly.No further complications were reported/are anticipated.

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 2018-oct-16.The patient indicated that they had their ins replaced on (b)(6) 2018- and it was not given to them so they do not know the current status of the explanted components.No further complications were reported/are anticipated.

• 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: 7660050
• MDR Text Key: 113510620
• Report Number: 3004209178-2018-14962
• 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
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2018
• Date Device Manufactured: 06/19/2014
• 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): Required Intervention
• Patient Age: 65 YR