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

Model Number 97712

Device Problems Failure to Deliver Energy (1211); Unintended Collision (1429); Unstable (1667); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Communication or Transmission Problem (2896)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was reported that there were telemetry issues and a potential for an overdischarge.There was an overdischarge.The patient last felt stimulation in what they believe was (b)(6) of the year prior to the report.The manufacturer representative (rep) had done 5 physician mode recharge¿s (pmr) sessions the day of the report and had not been able to pull the implantable neurostimulator (ins) out of overdischarge.The rep was wondering what circumstances may generate that.The patient had a fall the week prior.The rep was unsure if that had any relation to the issue with getting the ins out of overdischarge.The ins was located in the right buttock but it not feel unusually deep.The patient was going to check with their insurance company to make sure the healthcare provider (hcp) was in their network.Then they were going to pursue having an x-ray taken to rule out the possibility of a flipped ins.There was no definitive follow up that had been scheduled at the time of the report.To the reps understanding, the patient had not yet had their x-rays and they hadn¿t heard when it was going to be scheduled.Then, the rep spoke to the hcp office and they indicated an x-ray was taken the week prior.The ins was flipped.There were plans being made for surgery but no definitive date had been set.The x-ray was done, however, of the wrong orientation.There was the x-ray of a non-flipped battery for the ap view (anterior ¿ posterior).They would ask them to do a ¿pa¿ (posterior-anterior) so orientation of the connector block was visible.Further information regarding the surgery and patient outcome has been requested.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant products: product id: 39565-65, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 97754, serial# (b)(4), product type: recharger.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the insurance agent that the patient's implantable neurostimulator (ins) was not functioning right and they needed a new battery.The patient reported that since implant the ins would not charge all the way.They were not sure if it was due to them not doing it correctly.At a certain point the ins would no longer take a charge.They had worked with the manufacturer representative (rep) for several hours but it was ineffective.The patient also noted that they had pain in their bottom.They had diagnostics like x-ray and ultrasound done but they did not know the results.It was reported by the rep that the physician was awaiting insurance approval for surgical revision.In addition they report an alleged overdischarge.Relevant medical history includes non-malignant pain and failed back surgery syndrome.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

(b)(4).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

Additional information received from the manufacturer representative reviewed that the rep had met with the patient on (b)(6) 2015 due to an inability to charge.They could not communicate with the device.The patient could not remember the last time she had tried to charge.It was reviewed that the rep attempted 5 physician mode rechargers (pmrs) that were unsuccessful.X-rays had been recommended and the battery didn't appear to be flipped.A fall had been mentioned but the patient could not remember when.The device was replaced and there were no complications.

Manufacturer Narrative

Analysis of the returned neurostimulator model 97712 serial # (b)(4) showed no significant anomalies and had a reduced capacity due to overdischarge.Telemetry was okay after performing a physician mode recharge (pmr) recovery.No recharging issues were observed.

Manufacturer Narrative

No eval explain code.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 MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4853456
• MDR Text Key: 5935840
• Report Number: 3004209178-2015-11839
• 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,company representative,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/28/2015

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: 08/28/2014
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/28/2015
• Initial Date FDA Received: 06/18/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 01/28/2016
• Supplement Dates FDA Received: 10/22/2015; 12/15/2015; 02/08/2016; 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2013
• 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: 00051 YR