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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 Migration or Expulsion of Device (1395); Unstable (1667); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Pain (1994)
Event Date 10/21/2021
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) for unknown indications for use. It was reported that the patient had been experiencing abdominal pain since replacing her spinal cord stimulation (scs) device in (b)(6) 2021. She complained that when she got up or bent down the implant moved and it caused a lot of pain. The patient had not been able to get a hold of the doctor. A rep was emailed to coordinate a meet between the clinic and the patient. The issue was not resolved as of 21-oct-2021. No surgical intervention occurred or was planned. The patient was alive with no injury.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12686173
MDR Text Key278129440
Report Number3004209178-2021-15804
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 Foreign,Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/28/2021
Device Model Number97702
Device Catalogue Number97702
Was Device Available for Evaluation? No
Date Manufacturer Received12/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/10/2020
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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