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

Model Number 97712

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)

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

Event Date 07/28/2016

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient via healthcare provider reported that they cannot communicate with their implantable neurostimulator using with program er, with or without the antenna attached.The patient reported that they had not used their device in about a year; it was in overdischarge.The patient has not attempted to re-establish stimulation until today to put into mri mode.It was noted that the patient needs to have an mri done prior to spine surgery, and the ins and leads will be removed at that time.No patient symptoms were reported.The patient was implanted for spinal pain and cervical/neck.

Event Description

Additional information was received from a health care professional (hcp) reporting that the patient had only been seen once in the office within the last year.No further information was available.

Manufacturer Narrative

Additional review determined (b)(4) no longer applies to this event.

Event Description

Additional information received from the healthcare provider (hcp) reported prior to explant, the consumer didn't use the device because it wasn't helping with their pain.It was noted the consumer never mentioned any device issues and was "all patient." the hcp hadn't had an contact with the patient after (b)(6) 2016.

Event Description

Additional information received from the manufacturer¿s representative (rep) reported the implantable neurostimulator (ins) was overdischarged as the consumer ¿gave up on charging.¿ the rep.Then reported seeing the power on reset (por) message even though the battery was charging normally but when they tried to interrogate the ins with the clinician programmer it gave a message saying ¿batteries are depleted, replace batteries now.¿ it was reviewed with the rep.This meant the same thing as the ins was depleted and they should continue to charge.No patient symptoms or further complications were reported.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative (rep) on 2017-apr-11.The rep stated that a device reset was performed on (b)(6) 2017.The patient called the rep on (b)(6) 2017 and the battery was already dead after fully charging the system to 100%.The battery was unable to hold a charge from completely full to empty for more than 24 hours.Battery replacement indicated.This was why the patient had stopped charging in the first place.The issues have not been completely resolved yet.The patient has an appointment with their healthcare professional (hcp) on (b)(6) 2017 to discuss a battery replacement.The information provided was confirmed with the physician/account.No further complications were reported/are anticipated.

Event Description

Additional information was received from a manufacturer representative.It was reported that the ins battery was charged in the office to get settings and check impedances.They were albe to get 8 bars while charging.The cause of the rapid battery depletion was unknown.It was reported that a battery replacement was indicated for the patient and the manufacturer representative stated that the device would be returned for analysis.No further complications are anticipated.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacture representative (rep) on 2017-may-12.The rep stated that the device was still currently implanted in the patient.The rep would ship it to the manufacture for analysis once it is explanted.The explant has not yet been scheduled.The information was confirmed with the physician.No further complications were reported/are anticipated.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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: 5890600
• MDR Text Key: 52609273
• Report Number: 3004209178-2016-17299
• Device Sequence Number: 1
• Product Code: GZB
• 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,Followup,Followup,Followup
• Report Date: 05/25/2017

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: 03/28/2015
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/28/2016
• Initial Date FDA Received: 08/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; 05/12/2017
• Supplement Dates FDA Received: 09/21/2016; 10/18/2016; 04/11/2017; 04/25/2017; 05/11/2017; 05/25/2017; 09/25/2017
• Date Device Manufactured: 04/30/2014
• 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: 57 YR