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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37714
Device Problems Improper or Incorrect Procedure or Method (2017); Low Battery (2584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2018
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) regarding a patient with an implantable neurostimulator (ins) for an unknown indication for use. It was reported that the rep met with the patient per the account¿s request, to reprogram the patient¿s spinal cord stimulator (scs) therapy. The patient¿s ins was over-discharged. This was the 2nd over-discharge in a year. (other overdischarge documented in pe(b)(4)). Factors that may have led or contributed to the issue was the patient had a history of recharging non-compliance. An attempt to wake up the patient¿s battery will be followed up on (b)(6) 2018. The issue was no resolved at the time of the report. It was reported that the patient¿s previous overdischarge was on (b)(6) 2017. It was reported that the rep suspected the patient had not charged their battery since (b)(6) 2017, therefore, in their opinion, they stated it was unlikely that the ins was recoverable at this time. Additional information was received from the rep on 2018-07-05, reporting that following the appointment on (b)(6) 2018, the plan was for the patient to contact the rep the following day to schedule the battery recovery. However, the rep stated they did not hear from the patient, so they tried to contact them on (b)(6) 2018. They stated the phone had an automated message stating ¿the person you have called is unavailable¿, but there was no option to leave a voicemail. The rep stated they received a voicemail from the patient on (b)(6) 2018 requesting they return their phone call in regards to their over-discharged battery. The rep returned the call the same day, to the same number and again got the message, ¿the person you called is unavailable¿, with no voicemail options. The rep then contacted the patient¿s managing pain clinic, bsc and they provided me with the phone number they have on file for them. On (b)(6) 2018, they tried that number and it had an automated message stating the phone was ¿not set-up to receive voicemail¿. On 6/25 and 6/27, the rep called the original phone number (the number the patient had left them a voicemail from) and received the same unavailable message with no voicemail options. The rep had not spoken with the patient since the office visit on (b)(6) and they had not heard from the patient since they left the unreturnable voicemail on 6/21. They stated if they did not hear from them before, the next step was to meet with them again at their next scheduled appointment with their pain doctor on 8/2. No surgical intervention is planned or scheduled at this time. The overdicharge was not resolved and the provide information was confirmed with the physician/account. No further complications were reported/anticipated.

 
Manufacturer Narrative

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

 
Event Description

Additional information was received from the manufacturer representative (rep) reporting that the patient was a no-show for his appointment on (b)(6) and no follow up appointment had been scheduled at that time. No further complications were reported/anticipated.

 
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Brand NameRESTORE SENSOR
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
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 Key7665032
MDR Text Key113513885
Report Number3004209178-2018-15110
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/14/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/14/2014
Device MODEL Number37714
Device Catalogue Number37714
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/14/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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