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); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2014

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 healthcare provider (hcp) regarding a patient with an implantable neurostimulator (ins) for the treatment of spinal pain via a manufacturer representative.It was reported that the healthcare provider (hcp) could not communicate with the ins because the patient had not been charging.Additional information was received from manufacturer representative (rep) reporting that they didn't have any more information on patient.It was when they received a call from the mri tech that patient could not communicate with the ins only then rep found out that the patient battery was overdischarged.Additional information was received from the patient and the rep.It was reported that the patient was seeing and end of service (eos) message displayed on the programmer after a recent physician mode recharge (pmr); the rep suspected the eos was due to a 3rd overdischarge.The rep stated that the patient "let battery die" and had one pmr/overdischarge in the past for which the rep conducted a pmr.The patient conducted a pmr on (b)(6) 2018 while on phone with the patient to bring the ins out of overdischarge in preparation for an unrelated mri; the rep stated that the patient said that pmr was only the 2nd time the patient conducted a pmr.The rep noted that the patient was planning to get a new ins if the eos was confirmed.No symptoms were reported.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 a manufacturing representative and a healthcare provider regarding the patient.The hcp reported that the patient had problems with the ins since implant.Additional information received from the manufacturing representative on 2019-08-02 indicated that the ins was overdischarged and incurred the third strike.The ins had to be replaced after 5 years.No further complications were reported or 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: 7607129
• MDR Text Key: 111244828
• Report Number: 3004209178-2018-13577
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2019

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: 10/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 06/15/2018
• Supplement Dates Manufacturer Received: 08/01/2019
• Supplement Dates FDA Received: 08/09/2019
• Date Device Manufactured: 11/21/2013
• 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: 45 YR