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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 Problem Insufficient Information (3190)
Patient Problem Shaking/Tremors (2515)
Event Date 08/20/2021
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 patient who was implanted with an implantable neurostimulator (ins) for spinal pain.Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt reported that they had their implant battery (97714) replaced because the implant was not functioning the way the implant should and their hand and arm shake came back; pt said they used the device for their hand and arm shake.Pss documenting past event that was reported by the pt on the call.See case # (b)(4) for the report of implant charging frequency and pain on left side by spinal cord.
 
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Brand Name
SURESCAN
Type of Device
STIMULATOR, 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 Key12491935
MDR Text Key272022515
Report Number3004209178-2021-14060
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169109483
UDI-Public00643169109483
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 consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/14/2018
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/15/2021
Initial Date FDA Received09/17/2021
Date Device Manufactured08/24/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
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