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

Model Number 8637-40

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

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 foreign healthcare provider (hcp) via a manufacturer's representative regarding a patient who was receiving an unknown drug via an implantable pump for an unknown indication for use. It was reported an error code indicating "pump stopped - code security or code safety" was received. The representative provided an image of an physician programmer error message. The error message indicated the pump had stopped due to safety count. There were no reported symptoms. No complications were reported or anticipated. The initial reporter and serial number of the pump were provided. It was unknown on what date the error message was seen. The drug being delivered at the time of the event was unknown. It was unknown what actions were taken to resolve the issue. Additional information was received. It was stated it was unknown when the pump was implanted. The pump was explanted in (b)(6) of 2018. When asked why the pump was explanted, the representative stated, "it was reported an error code indicating "pump stopped - code security or code safety" was received. The representative provided an image of an physician programmer error message. The error message indicated the pump had stopped due to safety count. There were no reported symptoms. No complications were reported or anticipated. ".

Manufacturer Narrative

Review of the initial interrogation of the pump indicated the pump had been delivering morphine (2. 7 mg/ml), ropivacaine (9. 2 mg/ml), and ziconotide (0. 9 mcg/ml). Analysis of the product has not been completed as of the date of this report. A follow-up report will be submitted when analysis is complete. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Updated to adverse event product problem. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the pump identified no anomalies. (b)(4). 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

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: 7704648
• MDR Text Key: 114537103
• Report Number: 3004209178-2018-16237
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

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: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/14/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Is the Reporter a Health Professional?: No

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: 04/27/2017
• 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: 07/19/2018 Patient Sequence Number: 1