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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 37712
Device Problems Failure to Deliver Energy (1211); Charging Problem (2892); Electromagnetic Compatibility Problem (2927)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2021
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 patient who was implanted with an implantable neurostimulator (ins). The reason for call was that the pt reported they have two ins and they believe both are "gone". Pt was in the hospital on thursday and had their heart shocked twice; pt asked the doctor if shocking his heart would affect the stimulators and the doctor said it shouldn't. ¿patient had a cardio-version on (b)(6) and since then has not had therapy. Unknown if patient has patient programmer or if therapy was turned off prior to cardioversion. ¿pt said since then, the ins are not working; they can recharge one, but it doesn't "come online" after charged and wouldn't send out stuff. Pt said they told the doctor to call the manufacturer before shocking their heart, but they were told that it had been too long, they had used medication, but their heart wasn't converting over and was beating at 200 beats per minute. Reviewed cardioversion and defibrillation affects on the ins, and recommended pt follow up with healthcare provider (hcp) or manufacturing representative (rep) to check the ins in person. Pt became escalated and said that the rep told them to contact patient services and he thought the rep made them feel like they were being bothered. Pt went on to say that at their next appointment they would try to find another company who would be more helpful. Asked for the name of the rep that the pt spoke with and pt said they have been given three different representatives. Pt said one that they used to have is no longer with the company. Pt said last time their ins was replaced, the rep who put in, didn't seem to know what they were doing, didn't program or start it after the surgery, and they had to have another rep come in to program it. Pt requested contact from field reps. The issue was not resolved. ¿patient is being released (b)(6) 2021 from hospital and does have an appointment¿with managing hcp either thursday or friday that week. ¿the patient was redirected to their healthcare provider to further address the issue. No symptoms were reported.

 
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Brand NameRESTORE ULTRA
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12371904
MDR Text Key268288360
Report Number3004209178-2021-12963
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 CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 08/26/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/26/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/14/2012
Device MODEL Number37712
Device Catalogue Number37712
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/14/2011
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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