MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Output Problem (3005)

Patient Problems Muscular Rigidity (1968); Muscular Rigidity (1968); No Code Available (3191)

Event Date 12/01/2017

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 healthcare provider (hcp) via a company representative (rep) regarding a patient receiving intrathecal lioresal 500 mcg/ml at 191. 36 mcg/day via an implanted pump for intractable spasticity. The rep was called to assist in a pump replacement and possible catheter revision. The patient had experienced an increase in spasticity for the last eight months (2017) despite increased dosing. The home infusion nurse had noticed volume discrepancies for the last eight months where the expected volume was less than the actual residual volume aspirated (i. E. Last refill on (b)(6) 2018 was expected residual volume (erv)
=
10ml and the actual residual volume (arv)
=
14. 5 ml. It was noted there had been inconsistent reports on whether a catheter access port dye study had been performed. The pump logs were checked and there were no alarm present. The patient was not experiencing symptoms with withdrawal, but had increased spasticity. The rep was unsure whether the patient had received therapeutic bolus for symptoms. The change in therapy/symptoms was gradual. The rep was in the operating room (or) with the managing physician. It was reported the product would be returned. The rep also inquired if the pump was replaced and the catheter was unremarkable, what dose to start at. It was reviewed this was a medical decision and to consider trialing a single bolus. No further complications were reported/anticipated or expected.

Manufacturer Narrative

Analysis of the pump found no anomaly. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7728795
• MDR Text Key: 115347814
• Report Number: 3004209178-2018-16877
• Device Sequence Number: 0
• Product Code: LKK
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018
• 2 Devices were Involved in the Event: 1 2
• 2 Patients were Involved in the Event: 1 2
• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2013
• 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: 07/27/2018 Patient Sequence Number: 0