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

Model Number 8637-20

Device Problems Pumping Stopped (1503); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Chills (2191); Malaise (2359); Sweating (2444); Ambulation Difficulties (2544); No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2018

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 receiving unknown medication at unknown concentration and dosage via an implantable infusion pump for the treatment of non-malignant pain and chronic low back pain.It was reported that the patient's pump was going to be replaced on (b)(6) 2018 because "the current pump is not working well." there was no reported symptom and no medical or therapy problem associated with small parts was reported.Event date was unknown.No further complication was reported.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp).The cause of the pump not working well was determined to be the pump was at end of life.The patient was scheduled for a replacement of the pump in a few weeks.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a hcp via a manufacturer representative.The pump was delivering morphine (45mg/ml at 11.6 mg/day).It was reported that the patient experienced increased pain.The physician performed a rotor study and determined the pump was not working properly on (b)(6) 2018.No environmental, external, or patient factors were reported to have caused this issue.The pump was replaced on (b)(6) 2018.The issue was resolved and the patient was "alive - no injury." there were no further complications reported at this time.

Manufacturer Narrative

The pump was returned, and analysis found pump/motor had o-ring wear.No significant anomaly.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.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare provider (hcp) via a device manufacturer representative.It was reported that the patient experienced increased pain in may which was why the rotor study was performed.The pump when replaced was at exactly 6years of service, which was considered by the doctor to be normal life of pump. no further complication was reported.

Manufacturer Narrative

(b)(4) is no longer applicable for this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on 14-aug-2018 from the patient who reported that the pump was replaced because the ¿gears failed¿.About 2 months before the pump was replaced on (b)(6) 2018, the patient was sick in bed for 5 days with sweats and chills.She also had pain in her legs and couldn¿t walk.The symptoms had come on suddenly.She saw the hcp (healthcare professional) who took an x-ray while requesting a bolus and saw that the gears in the pump were not turning.No further complications were reported/anticipated.

• 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
• MDR Report Key: 7658227
• MDR Text Key: 113010556
• Report Number: 3004209178-2018-14866
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• 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: 07/25/2018
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 55