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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Device Operates Differently Than Expected (2913); Environmental Compatibility Problem (2929); Insufficient Information (3190)

Patient Problems Diarrhea (1811); Nausea (1970); Pain (1994); Vomiting (2144); Therapeutic Response, Decreased (2271); Anxiety (2328); Shaking/Tremors (2515)

Event Date 10/25/2017

Event Type  Injury  

Manufacturer Narrative

Analysis results were not available 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.

Event Description

Information was received from a healthcare provider (hcp) via a clinical study regarding a patient receiving hydromorphone 21.0 mg/ml for a total dose of 2.997 mg/day via an implantable pump for non-malignant pain and degenerative disc disease/herniated disc pain.It was reported on (b)(\6) 2017 the patient experienced shakiness that began in the morning and increased pain.Intervention on (b)(6) 2017 included medication was administered.On (b)(6) 2017 the patient experienced nervousness and shakiness.It was noted that the patient was aware of withdrawal symptoms and was prescribed clonidine for management.On (b)(6) 2017 the patient experienced vomiting, nausea, diarrhea, and increased pain.It was noted that the patient had been diagnosed with uterine cancer and was tapering pump for radiation therapy.The outcome of the event was noted as ongoing.The clinical diagnosis was intrathecal medication withdrawal symptoms.The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.The relatedness to the medication (hydromorphone) was noted as related and the drug action that caused the event was a decrease in dose.The event date was (b)(6) 2017.No further complications were reported/anticipated.Additional information was received from a healthcare provider (hcp) via a manufacturer representative on 2018-feb-12.It was reported that the patient underwent radiation therapy for cancer and they thought the pump was "potentially not working" due to the radiation, so the pump was replaced.It was noted that they were able to read the pump and confirm the pump status, but event logs were not read.It was noted that the pump had delivered hydromorphone (21mg/ml at minimum rate - 0.121mg/day).Additional information was received from a consumer on 2018-feb-15, stating that the pump was exposed to radiation from (b)(6) 2017 to (b)(6) 2018.It was noted that the pump was extremely high at " 12 something, or 16 something" but was shut down to minimum rate when the patient was having radiation.It was noted that magnetic resonance imaging (mri) was performed to check the catheter tip and the hcp replaced the pocket.

Manufacturer Narrative

The pump was returned, and analysis found no anomalies.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from healthcare provider via a clinical study reported the patient's baseline weight was (b)(6) lbs.It was noted the patient's pump was explanted and replaced on (b)(6) 2018.The event status were unknown.No further complications were reported/anticipated.

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 received from a healthcare provider via a clinical study updated the device diagnosis to other radiation treatment over the site where the pump was implanted.

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 a healthcare provider via a clinical study reported the device diagnosis as other pump in radiation field.Stopped functioning.

Manufacturer Narrative

Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare provider via a clinical study reported radiation therapy damaged the pump.The issue resolved without sequelae on (b)(6) 2018.

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): 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: 7316379
• MDR Text Key: 101598745
• Report Number: 3004209178-2018-04432
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• 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: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 65