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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97714
Device Problems Failure to Deliver Energy (1211); Therapy Delivered to Incorrect Body Area (1508)
Patient Problems Headache (1880); Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)
Event Date 07/27/2021
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's representative regarding an external device. The patient's husband (caller) reported that the patient was trying to adjust the modulation on their device with their patient programmer and it wasn't working. The caller opened the battery compartment to change the batteries and found that the batteries were corroded. The caller reported that now the programmer would not work. They also noted that the battery compartment was now difficult to open where before they had no issue. The caller reported that they were making the call on the patient's behalf because the patient had to lay down while recharging their implant to center the recharger. Additional information received from the patient's husband on 30-jul-2021. It was reported that they received the new patient programmer. When they attempted to adjust the new programmer to the implant, the patient was not able to feel stimulation on the left side no matter how high they turned the stimulation intensity up. The issue started with the new programmer. The patient's program number 1 was for the left side but that programmed stimulation was no longer assisting the patient. The patient was redirected to follow up with their healthcare provider. No further complications reported.

 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12276163
MDR Text Key265058454
Report Number3004209178-2021-11922
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,Followup,Followup
Report Date 08/31/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/04/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2019
Device MODEL Number97714
Device Catalogue Number97714
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 Received08/17/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/28/2018
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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