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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 97713
Device Problems Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The manufacturer representative reported the patient was charging the implant fully and it only lasts about one hour. Unknown if previous overdischarges have occurred. Troubleshooting reviewed to meet patient in clinic to assess diary and also capture recharge stats. Caller will plan on meeting with patient possibly next week. Outcome unknown at this time. On (b)(6) 2021 (b)(4): the rep followed-up on this case while with the patient. The caller indicated that when the ins was interrogated the clinician tablet displayed an alert that said the device has been reset. The tablet had the patient information fields blank. The caller entered the patient name and other patient information. The caller provided the following programming information: therapy parameters group a1 2+ 3- 4+ amplitude: 5v pw 450 rate: 40hz therapy imp: 505ohms. Recharge diary information: 9/17 charged from 25-50% for a duration of 49 min 3/29 charged from 0 no time duration 3/29 charged from 0-25% for a duration of 57 min 4/10 charged from 0-25% for a duration of 33 min 7/22 charged from 0-25% for a duration of 80min 11/10 charged from 0-25% for a duration of 51 min the device date was set to (b)(6) 2003, the caller corrected the date. The patient claimed that when they charge the ins icon on the recharger shows that it is fully charged. The patient claimed to have charged this morning. Tss reviewed information about charging. The caller attempted to start a charging session with the ins using the patient's recharger. During the session the recharger was displaying 8 coupling bars and it was charging from 0 to 25%. The caller will have the patient continue to charge and will have them attempt to charge more frequently. On 2021-09-24 mpxr 881397 (rep) additional information received. It was reported the ins was replaced. Patient wanted a more recharge friendly device. Battery went dead because he was having issues recharging. He wanted a recharge device that was more user friendly. No impedance issues on leads w new battery. He stated that he let the battery go dead prior to the replacement. It couldn be interrogated. Issue is resolved.
 
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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 Key12547753
MDR Text Key273838818
Report Number3004209178-2021-14578
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
Reporter Occupation
Type of Report Initial
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2016
Device Model Number97713
Device Catalogue Number97713
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/17/2015
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: 09/29/2021 Patient Sequence Number: 1
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