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

Model Number 97714

Device Problems Unintended Collision (1429); Battery Problem (2885); Charging Problem (2892)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The consumer reported that the implant runs out so fast he was charging every two days since three months ago.The patient stated he has not changed the settings or been recently reprogrammed.The patient did note he had a few falls but wasn¿t sure when.The patient was directed to follow-up with a healthcare provider to have the system checked.The indications for use were spinal stenosis and non-malignant pain.No patient symptoms reported.

Manufacturer Narrative

Product id: 37791, serial# unknown, product type: recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received and it was reported that the patient wasn't getting coupling bars on the recharger screen.They repositioned 19 times that day and they were able to charge the implant fine 2 days prior.The ins charge level only lasted for 2-3 days, so they had to charge often.The patient stated they had a lot of trauma.The recharger showed the reposition antenna icon screen.No further complications were reported or anticipated.

Manufacturer Narrative

Concomitant medical products: product id: 37791, product type: recharger.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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 8258600
• MDR Text Key: 133524198
• Report Number: 3004209178-2019-01249
• 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: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2019
• Date Device Manufactured: 11/12/2013
• 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: 77 YR