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

Model Number 97702

Device Problems Premature Discharge of Battery (1057); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  malfunction  

Manufacturer Narrative

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 (ins) for spinal pain.Information was reported that the patient has seen an end of service (eos).The patient's device is off and no longer providing therapy.The patient was advised to contact their managing healthcare provider (hcp) to schedule replacement surgery.The patient reported that she can't turn her implant on and that her implant stopped working.The patient reported that she started seeing elective replacement indicator (eri) for a while before seeing eos.The patient stated the implant had "only" lasted for 3 years.No further complications were reported.No additional patient symptoms were reported.

Manufacturer Narrative

A supplemental report will be sent when analysis results are available.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the patient reporting that the eos (end of service) message was first noticed in (b)(6) 2018.They reported that the cause of the battery not lasting as long as the patient expected was unknown as it was not a rechargeable ins.It was reported that no actions were taken to resolve their battery not lasting as long as they expected.They stated they had an appointment on (b)(6).The issue of their battery not lasting as long as they expected had not been resolved.It was reported that the patient weighed (b)(6) at the time of the event.No further complications were reported/anticipated.

Manufacturer Narrative

Analysis determined that there were no significant anomalies and that the battery depletion was normal.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: 7605942
• MDR Text Key: 112147775
• Report Number: 3004209178-2018-13552
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• 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: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2015
• 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: 82 YR
• Patient Weight: 85