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

Model Number 8637-20

Device Problems Filling Problem (1233); Increase in Pressure (1491); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Material Deformation (2976)

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

Event Date 11/15/2018

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 consumer regarding a patient who was receiving prialt at an unknown dose and concentration via an implantable pump for non-malignant pain. It was reported that the patient moved to another state and the pump went dry "a couple of weeks ago". It was noted the critical alarm was going off. No symptoms were reported. No further issues were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative. It was reported that the pump was still empty, and considerations were requested.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative on 2019-mar-25. It was reported that the cause of the inability to fill the pump was not determined.

Manufacturer Narrative

Analysis of the pump identified a concave outer shield which affected in-vivo use consistent with the damage caused by scuba diving. The previously reported evaluation conclusion, method, and result codes no longer apply. 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 a healthcare provider via a manufacturer representative on 2019-apr-22. It was reported that the pump was concave during replacement on (b)(6) 2019. It was noted that the patient did scuba dive.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative on 2018-dec-27. It was reported that the patient was waiting for a few new clinics to return their calls to take them on as a new patient. It was unknown whether the empty pump had been resolved.

• 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
• MDR Report Key: 8159810
• MDR Text Key: 130672691
• Report Number: 3004209178-2018-27547
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/14/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 12/13/2018 Patient Sequence Number: 1