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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 97702
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Electro-Static Discharge (2149)
Patient Problems Pain (1994); Burning Sensation (2146); Electric Shock (2554); Insufficient Information (4580)
Event Date 06/06/2021
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 representative regarding a patient who was implanted with an implantable neurostimulator (ins). It was reported that¿on (b)(6),¿ the patient's husband needed to shut patient's device off due to lightning storm that was close to their house. The lightning flashes were causing patient to report feeling "electrical pulses" in her hand. Stimulation therapy is for cervical placement. Technical services (tss) reviewed electrical pulses could be positional or electromagnetic interference (emi) related. This appears to be the first report by the husband since implant in (b)(6) 2021. Tss asked rep to find out if there have been any recent falls or trauma, if this has happened before. Suggested to monitor and have husband ask patient to move their head to different positions to see if that brings on the event again and monitor if there is another lightning storm again. Reviewed most conservative way to proceed if issues still happen during storm is to either turn down stim or turn therapy off until storm passes. Caller didn't have patient's settings to determine if close to patient's max threshold.
 
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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 Key12084997
MDR Text Key259492812
Report Number3004209178-2021-10109
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number97702
Device Catalogue Number97702
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/02/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/29/2021 Patient Sequence Number: 1
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