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

Model Number 97714

Device Problems No Device Output (1435); Unable to Obtain Readings (1516); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Insufficient Information (3190)

Patient Problem Therapeutic Response, Decreased (2271)

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 manufacturer's representative and a consumer regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient's ins was dead and had been jumpstarted.Once they charged the ins, eos occurred.The representative was able to read the battery to get programming however they were unable to turn the ins on.Impedances were checked and they showed as "xxx".The patient noted that coverage was good prior to letting the battery die.They had injections which were helping with their pain so they didn't charge the ins.The ins always helped with their legs more than their back and they were unable to try high frequency settings due to the recharging burden.They planned to refer the patient to their physician for a battery replacement- surgical intervention was planned but not yet scheduled.No further complications reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturing representative (rep).It was reported that the ins was overdischarged.The suspected cause of the eos was that ins being overdischarged for the 3rd time.Surgery has not been scheduled.Ins will be returned at the physicians discretion.Information has been confirmed.No patient symptoms or complications were reported in this event.

Manufacturer Narrative

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

Event Description

Additional information received from the representative.It was reported that the ins was replaced on (b)(6) 2019, and they were unable to return the ins for analysis as the hospital didn't allow the representative to have possession of the battery.No further complications reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient reporting that the patient was due to get their ins replaced on (b)(6) 2019.They were asked the reason for their replacement and they stated that ¿it was a little shorter than typically, but not a whole lot¿.It was asked why the patient¿s current ins would need to be replaced since its normal life was nine years.They stated that it was because the ¿ins was dead¿ and they stated that it had been overdischarged too many times.They were asked when it was determined that it no longer was working and the patient then became upset with all the questions (event date was asked but was unknown).It was indicated that the patient was going to get a primary cell battery and wanted to know if their current leads were compatible and it was reviewed that as long as the leads were still viable then they would be compatible.They stated that they were getting preoperative testing next week to see if the leads were still good.The patient stated that they were having trouble getting insurance to approve and did leave a message with the rep.The patient was redirected to follow-up with the healthcare provider (hcp).The event dates of the overdischarges and the issue of the ins no longer working were asked but were unknown.No response has been received at this time.No further complications were reported/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: 7964991
• MDR Text Key: 123701550
• Report Number: 3004209178-2018-22982
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2019
• Date Device Manufactured: 06/10/2014
• 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