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

Model Number 8637-20

Device Problems No Audible Alarm (1019); Intermittent Infusion (2341); Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); High Blood Pressure/ Hypertension (1908); Nausea (1970); Tachycardia (2095); Vomiting (2144); Therapeutic Response, Decreased (2271); Sweating (2444)

Event Date 02/27/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from healthcare provider regarding a patient receiving fentanyl, 6000mcg. /ml at 2881. 5mcg/day, bupivacaine 20mg/ml at 9. 6mg/day and clonidine 1500mcg/ml at 720. 4mcg/day via an implantable pump. The indications for use were non-malignant pain and chronic low back pain. The healthcare provider reported the patient was having withdrawal. The patient was experiencing diaphoresis, tachycardia, diarrhea, nausea, vomiting and abdominal pain. The patient was hospitalized. The healthcare provider was requesting a company representative to come and check the pump. Per the healthcare provider no alarms had been heard at this point. Additional information was received on (b)(6) 2017 from a company representative who reported they saw the patient and interrogated the pump. The logs showed a motor stall occurred (b)(6) 2017 @0715 and motor stall recovery (b)(6) 2017 @1732. The reporter denied any emi or magnetic interaction i. E. Mri. The reporter also stated the patient did not hear the audible alarm.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) on (b)(6) 2017. It was stated that an alarm was heard, but telemetry had not yet been performed. It was stated that the pump stopped working on (b)(6) 2017. The patient was in withdrawal and admitted to the emergency room (er). Additional information was received on (b)(6) 2017. The hcp requested to program the pump back to the original settings as on (b)(6) 2017 the representative programmed the pump to minimum rate mode because the patient was on intravenous (iv) fentanyl. They wanted the original pump setting programmed, so the patient could be taken off the iv fentanyl.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on 26-apr-2017 from a healthcare professional (hcp) and it was reported that they did not know why the patient did not hear the pump alarm.

Event Description

Additional information was received on 26-apr-2017 from a healthcare professional (hcp) and it was reported that the patient was initially in a hospital that the pump managing physician did not have access to. The pump was interrogated (b)(6) 2017 and found to be in a motor stall. The pump was set to minimum rate and the patient was admitted to the hospital. The patient had withdrawal symptoms, including hypertension. On (b)(6) 2017, the hospital wanted to see if the pump could be increased while the patient was in the hospital, but it couldn¿t be because the pump was in a motor stall. The patient was later transferred to a hospital in the city where the pump managing physician practiced and had hospital access. The patient's pump was replaced on (b)(6) 2017. The patient had a post-operative appointment on (b)(6) 2017. The patient was overall healing up well and the pain was back as baseline.

• 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: 6368136
• MDR Text Key: 100706526
• Report Number: 3004209178-2017-04809
• Device Sequence Number: 1
• Product Code: LKK
• 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

• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/14/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/27/2012
• 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 Treatment Data

Date Received: 03/01/2017 Patient Sequence Number: 1