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

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.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, 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 Key: 8743722
• MDR Text Key: 149486069
• Report Number: 3007566237-2019-01418
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• 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 Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• 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 Received: 06/28/2019
• 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