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

Model Number 8637-40

Device Problems Difficult to Advance (2920); Infusion or Flow Problem (2964)

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

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 05-dec-2005, udi#: (b)(4); product id: 8596sc, serial/lot #: (b)(4), ubd: 17-may-2009, udi#: (b)(4). 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 who was receiving an unknown medication via an implantable pump. Indication for use was non-malignant pain. The date of the event was unknown. It was reported that the healthcare provider (hcp) was doing a catheter access port (cap) dye study and was unable to aspirate form the cap. The hcp then pushed the dye thru the cap and catheter and saw a spread of dye on x-ray. No symptoms were reported. No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp) via a company representative. The inability to aspirate the catheter access port occurred (b)(6) 2019 (date unknown). Surgery was performed on (b)(6) 2019 to replace the catheter. The physician had to explant the entire system and could not get a new catheter in. The cause of the inability to aspirate the catheter access port was not determined. The inability to aspirate the catheter access port has been resolved as the system was explanted. The patient¿s weight at the time of the event was unknown.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp) via a company representative. The patient¿s spine was very difficult, and the doctor couldn't get the catheter in the intrathecal space. The catheter will be returned. The pump was delivering dilaudid 2. 5 mg per ml; 0. 65 mg per day and bupivicaine 2. 5 mg per ml; 0. 65 mg per day.

Manufacturer Narrative

The catheters were returned and analysis found no significant 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
• MDR Report Key: 8300912
• MDR Text Key: 134909710
• Report Number: 3004209178-2019-02312
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 02/04/2019 Patient Sequence Number: 1