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

Model Number 8637-20

Device Problems Pumping Stopped (1503); Volume Accuracy Problem (1675); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)

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

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath, serial#: unknown, implanted: (b)(6) 2018, product type: catheter.Product id: 8731, serial#: unknown, product type: catheter.Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown; product id: 8731, serial/lot #: unknown.Initial reporter occupation: healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient receiving intrathecal morphine 20 mg/ml at 4,5 mg/day via an implantable pump.The indication for use was not reported.It was reported a volume discrepancy occurred at the patient¿s last refill in (b)(6) 2018.The hcp attempted to aspirate the catheter via the sideport; there was no cerebrospinal fluid (csf) [flow].The catheter was disconnected from the pump; there was no csf [flow].In the back, the catheter connection (8731) was found and disconnected; there was no csf [flow] from the spinal segment.The decision was made to change the entire catheter.Elective replacement indicator (eri) was at 12 months, and the healthcare professional (hcp) decided to replace the pump as well.The pump would be returned to the device manufacturer with part of the catheter still attached to it.It was unknown if the issue was resolved.However, the patient's status was alive - no injury.There were no applicable environmental, external or patient factors reported that might have led or contributed to the event.The implant date, event date, patient age, patient weight, and medical history were unknown.Additionally, logs showed a motor stall occurred on (b)(6) 2018 at 15:21 with recovery on (b)(6) 2018 at 16:11.No patient symptoms were reported.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Pump analysis found overinfusion (undetermined root cause).Neu_unknown_cath analysis found no significant anomalies, 8731 catheter analysis found no significant anomalies method code applies to the pump, neu_unknown_cath, and the 8731 catheter result code applies to the pump, result code applies to neu_unknown_cath and the 8731 catheter; conclusion code applies to the pump, conclusion code applies to neu_unknown_cath and the 8731 catheter.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): 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: 7727182
• MDR Text Key: 115256513
• Report Number: 3004209178-2018-16840
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 09/14/2018; 08/08/2018
• Supplement Dates FDA Received: 09/21/2018; 10/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1570-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention