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

Model Number 8637-20

Device Problems Pumping Stopped (1503); Failure to Deliver (2338)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 03/15/2018

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 professional (hcp) via a company representative regarding a patient receiving gablofen (200 mcg/ml at 234 mcg/day) via an implanted pump. The indication for pump use was intractable spasticity. It was reported that the patient had a pump refill on (b)(6) 2018. At that time, the pump logs showed that a motor stall occurred on (b)(6) 2018 and no recovery took place. But when the pump was interrogated at the refill on (b)(6) 2018, it showed a recovery occurred. At the refill, the pump aspirated back the correct amount of drug as if it was working and the patient never had a return of symptoms. It was noted that if the pump had stalled and not recovered it should have returned 19. 3 cc as stated in the telemetry, but instead it aspirated back 3 cc. Therefore, it was thought that the pump stalled and recovered in march but did not show the recovery in the logs until the pump was interrogated in july. The pump was replaced. The issue was resolved at the time of the report. The patient status w as reported as ¿alive ¿ no injury¿. With regards to if there were any environmental, external, or patient factors that may have led or contributed to the issue, ¿n/a¿ was noted. It was noted that the hcp had no further information regarding the event. No further complications were reported/anticipated.

Manufacturer Narrative

Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received and the logs showed stopped pump period may exceed tube set on (b)(6) 2018. No rotor or dye study was performed. The patient recovered without sequela. No further complications were reported or anticipated.

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.

Manufacturer Narrative

Analysis of the pump revealed no anomaly. 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): 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7732421
• MDR Text Key: 115456528
• Report Number: 3004209178-2018-16951
• 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,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/14/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• 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: 05/27/2015
• 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: 07/30/2018 Patient Sequence Number: 1