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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Filling Problem (1233); Increase in Pressure (1491); Material Deformation (2976)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)
Event Date 05/12/2019
Event Type  Injury  
Manufacturer Narrative
Citation: goel, v. , patwardhan, a. M. , ibrahim, m. , shankar, h. , schultz, d. Indented intrathecal drug delivery system with loss of reservoir volume. American society of regional anesthesia & pain medicine. 2019; 0:1-3. Please note that this date is based off the date of publication as the actual event date was not provided. It was not possible to match this event with any previously reported event. If information is provided in the future, a supplemental report will be issued. [(b)(4)].
 
Event Description
Summary: in this study, they report that two patients, who underwent elective revision surgery, were found to have reduced reservoir volumes and indented bottom shield of intrathecal drug delivery system (idds). Reported event: a (b)(6)-year-old man stable on idds medications for chronic neck and upper back pain was found to have an irreversible reduction in reservoir volume from 40 to 28 cc on routine refill appointment. Despite having stable pain control, the reservoir volume decreased from 40 to 22 cc and subsequently to 17 cc when the patient had inadequate pain control. During replacement surgery, the posterior shield of the idds was found to be collapsed. The patient had exposure to hyperbaric oxygen treatments for chronic non-healing wounds of the lower extremities.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8743722
MDR Text Key149486069
Report Number3007566237-2019-01418
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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: 06/28/2019 Patient Sequence Number: 1
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