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

Model Number 8637-20

Device Problems Mechanical Problem (1384); Pumping Stopped (1503); Application Program Problem (2880)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2018

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 health care provider (hcp) via a device manufacturer representative regarding a patient receiving fentanyl (6000 mcg/ml at 2423.7 mcg/day) and baclofen (400 mcg/ml at 161.58 mcg/day) via an implantable infusion pump.The indications for use were noted to be non-malignant pain and other.It was reported that a stall was seen during a pump interrogation.The patient had not recently had an mri.The pump stalled on (b)(6) 2018, recovered on (b)(6) 2018, stalled again on (b)(6) 2018 and tube set occurred on (b)(6) 2018.The stall was still active at the time of the report.No patient symptoms were reported.The patient's weight was provided.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4) as the symptoms reported were clarified to not be related to the pump or therapy.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a health care professional (hcp) via a device manufacturer representative on 2018-oct-01.It was reported the "other health issues" which delayed the patient's surgery were pneumonia unrelated to his pump.The circumstances which led to the pneumonia were noted to be "life." the patient had no symptoms related to the reported motor stall.No further complications were reported.

Manufacturer Narrative

Analysis of the implantable infusion pump (b)(4) found a stall due to wear and/or corrosion and/or lubrication, a stall due to shaft bearing and overinfusion of an undetermined cause.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The type of report was updated from previously being a reportable malfunction to now a reportable serious injury regarding additional information received.Update: the previously applied patient code (b)(4) was replaced with (b)(4).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 company representative.The pump had stalled since early(b)(6) according to hcp.The pump was explanted.Replacement of the pump had been postponed due to other health issues with the patient.Patient presented today ((b)(6) 2018) for a replacement.The explanted pump was to be returned to the manufacturer.Diagnostics/troubleshooting performed included the logs having been checked.Environmental/external/patient factors that may have led or contributed to the issue was indicated as none.The issue was resolved at the time of the report.The patient was without injury regarding their status at the time of the report.The pump was reported as having administered compounded baclofen with concentration 400 mcg/ml at a dose rate of ¿40 mcg/ml¿ and fentanyl with concentration 6000 mcg/ml at a dose rate of 600 mcg/day.Other medications (oral, etc.) the patient was taking at the time of the event was unable to be obtained.The patient¿s weight was indicated as being 221 pounds.The patient¿s medical history included chronic pain.

• 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: 7752077
• MDR Text Key: 116902227
• Report Number: 3004209178-2018-17441
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2012
• 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-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 100