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

Model Number 8637-40

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Analysis of the pump on (b)(6) 2018 revealed no anomaly. As received, the estimated elective replacement indicator was at less than one month. As per the pump¿s log, lioresal with concentration 2000. 0 mcg/ml was being administered at a simple continuous dose rate of 275. 8 mcg/day as of (b)(6) 2017. 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.

Event Description

Additional information was received from the company representative (rep). The rep was not aware of any patient symptoms. It was indicated the device would be shipped back to the manufacturer on (b)(4) 2018.

Manufacturer Narrative

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.

Event Description

Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving an unknown type of baclofen via an implanted intrathecal pump. The indication for use regarding the pump was intractable spasticity. It was reported that possible premature battery depletion occurred. The event date was asked, but unknown. The pump was explanted on (b)(6) 2018. It was noted that the pump was on the recall list. It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue. It was unknown what diagnostics/troubleshooting was performed. As an action/intervention taken to resolve the issue, it was reported that the pump was replaced. The issue was resolved at the time of the report. The patient was without injury regarding their status at the time of the report. The patient¿s medical history and weight were asked, but was unknown. Other medications the patient was taking at the time of the event could not be obtained as they were not available to the manufacturer. The pump was to be returned for analysis. On (b)(6) 2018 a company representative further reported that the pump administered baclofen with concentration 2000 mcg/ml at a dose rate of 275 mcg/day. Regarding the report of possible battery depletion and if a low battery was verified in the event logs, it was indicated that this was not verified, and it was believed the healthcare provider office assumed it was premature battery depletion since the pump was on a recall list. It was indicated that elective replacement indicator (eri) had occurred. The average daily flow rate that the pump was programmed with was 275 mcg/day. No further patient complications have been reported as a result of this event.

• 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: 7262322
• MDR Text Key: 103333383
• Report Number: 3004209178-2018-03070
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/14/2011
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2010
• 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: 02/09/2018 Patient Sequence Number: 1