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

Model Number 8637-20

Device Problems Pumping Stopped (1503); Intermittent Infusion (2341); Battery Problem (2885)

Patient Problems Memory Loss/Impairment (1958); Therapeutic Response, Decreased (2271); Malaise (2359); Cognitive Changes (2551)

Event Date 12/13/2017

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 healthcare provider on 2017-dec-16 regarding a patient receiving dilaudid (20.0 mg/ml at 2.950 mg/day) via an implanted infusion pump.The indications for use included non-malignant pain and chronic low back pain.It was noted that the patient had to have mris in the past for other issues.It was further specified that the patient's spine was collapsing slowly as of 2016, and the patient had a c5 that was collapsed in the neck.It was reported that the patient presented to the emergency room on (b)(6) 2017 stating that the pump was alarming and wasn't working.It was noted that at the time of report, the pump was not currently alarming, and the patient was able to successfully use their personal therapy manager (ptm) to deliver a bolus.No clinician programmer was available to interrogate the pump, but per the patient, the ptm displayed a "call your doctor" picture.No code was reported and no patient symptoms were initially reported.Additional information was received from a consumer on (b)(6) 2017.It was further reported that the patient saw code 8476 on the ptm on wednesday or thursday (relative to (b)(6) 2017), indicative of a motor stall, but now it was resolved and the pump was working.It was confirmed that the patient was able to use the ptm again.It was noted that this was the first time the patient had this issue, and per the patient, it was thought that the issue was that the pump battery was getting low.When the event occurred, it was noted that the patient wasn't feeling well.The patient was reportedly going through withdrawal "or like detox," and wasn't making sense.It was specified that the worst day was (b)(6) 2017.The patient was reportedly in such a delusional state when the event occurred that they didn't take their xanax for a few days and that was bad.The patient did not remember much at all.The patient was to follow-up with their managing healthcare provider.No further complications were reported or anticipated.

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 (hcp) via a manufacturer representative on (b)(6) 2017.It was reported that after the hcp read the pump logs on (b)(4) 2017, it was shown to have multiple motor stalls and recoveries.Oral medications were given to the patient at the time of the stalls because the patient went through withdrawal.There were no known environmental, external, or patient factors that were thought to have led or contributed to the issue, and the issue was considered unresolved at the time of report.No surgical intervention had occurred, but was planned.It was unknown if the surgery had been scheduled.The patient's status at the time of report was alive - no injury.

Manufacturer Narrative

The previously applied device code (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer.It was reported that their pump had stalled and that¿s why they had to get the pump replaced.

• 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: 7130000
• MDR Text Key: 96022570
• Report Number: 3004209178-2017-26277
• 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
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2019
• Date Device Manufactured: 09/23/2011
• 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: 58 YR