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

Model Number 97714

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Failure to Deliver Energy (1211); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Electric Shock (2554)

Event Date 08/01/2017

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 manufacturer representative (rep) via a patient with an implantable neurostimulator (ins) for spinal pain.The patient believes that their stimulation is turning on and then turns off and shocks them.No troubleshooting has taken place at this time.The rep has no additional information to offer.The issue was not resolved but the patient was noted to be alive with no injury.No further complications were reported/are anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer regarding the patient.It was reported that the cause of the stimulation turning off and on and the shocking had not been determined.The patient stated that no actions were taken to resolve these issues.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer.It was reported that since around (b)(6) 2017 (exact date was unknown), the noticed the ins did not seem to be working; like it had quit because it was not helping the patient at all with pain relief.The patient had tried charging their ins but the stimulation still would not run.They also tried adjusting stimulation with the patient's programmer without resolve.They were redirected to the doctor to check the device and possible reprogramming.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 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: 7598420
• MDR Text Key: 111029068
• Report Number: 3004209178-2018-13371
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup,Followup
• Report Date: 10/04/2018

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: 12/14/2017
• 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: 06/11/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 07/02/2018; 07/02/2018; 08/01/2018; 08/08/2018
• Supplement Dates FDA Received: 07/10/2018; 07/10/2018; 08/05/2018; 10/04/2018
• Date Device Manufactured: 01/23/2017
• 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: 81 YR
• Patient Weight: 68