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

Model Number 97714

Device Problems Failure to Interrogate (1332); Unintended Collision (1429); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Communication or Transmission Problem (2896)

Patient Problem Stroke/CVA (1770)

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 consumer concerning patient with an implantable neurostimulator (ins) for failed back surgery syndrome and spinal pain.It was reported the ins was in overdischarge.The patient reported he had a stroke about a year ago and thinks it may have been caused by the ins system.The patient also reported he fell on (b)(6) 2019 andlanded directly on the ins.The manufacturer representative (rep) attempted to interrogate the ins to no avail.They tried using the controller and could not connect.Trickle charge was not an option and the patient was contemplating system explant versus replacement.No further complications were reported/anticipated.

• 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: 9649503
• MDR Text Key: 177168468
• Report Number: 3004209178-2020-02236
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2020
• Date Device Manufactured: 12/19/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 51 YR