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

Model Number 8637-40

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problems Diarrhea (1811); Therapeutic Response, Decreased (2271); Anxiety (2328)

Event Date 02/19/2018

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 healthcare provider (hcp) via a company representative regarding a patient who was previously receiving fentanyl with concentration 1000 mcg/ml at a dose rate of 350 mcg/day and bupivacaine with concentration 25 mg/ml at a dose rate of 8. 75 mg/day via an implantable pump for non-malignant pain. It was reported that an alarm was heard and confirmed by telemetry. Regarding the alarm that was occurring, elective replacement indicator (eri) had occurred. The eri/alarm was unexpected. They had put the pump into a minimum rate and provided oral meds to the patient in the meantime. The patient started having a little diarrhea and thought she was going in withdrawal right after they put the pump in a minimum rate and gave her oral meds. It was stated that they were thinking it was more of a psychological thing. They planned on replacing the pump within a month. It was indicated that the nurse practitioner was the patient¿s current managing hcp. The pump was currently administering fentanyl with concentration 1000 mcg/ml at a minimum rate and bupivacaine with concentration 25 mg/ml at a minimum dose rate. No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received via a healthcare provider (hcp). The cause of the unexpected eri/alarm was indicated as having been unknown at this point. It was clarified that the patient was not in withdrawal. The pump failed one week before an appointment. The patient was having a panic attack. Device replacement was pending authorization and scheduling. They were covering the patient with oral opana. The unexpected eri was not resolved. The patient¿s diarrhea was resolved. Regarding the current status of the affected device, the pump was placed in a minimum rate and was pending replacement. The patient¿s weight at the time of the event was (b)(6).

Manufacturer Narrative

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

Event Description

Additional information was received from a nurse practitioner (np). The np called back to silence the elective replacement indicator alarm. The alarm was successfully silenced.

Manufacturer Narrative

Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received via a company representative. The pump was returned for analysis. As per the manufacturer's device registry, the pump was explanted and replaced on (b)(6) 2018.

Manufacturer Narrative

Analysis of the pump revealed a voltage related elective replacement indicator (eri) or end of service (eos) of an undetermined cause. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Update: the hybrid was sent for further testing to establish root cause. The hybrid was however found to be fully functional with nomimal static current drain 3. 16 a average. There was no change in the system current drain after approximately four hours in a temperature chamber at approximately 60ºc. No physical anomalies were observed. The cause of the premature battery depletion (pbd) could not be determined. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Update: the previously applied conclusion code has been replaced. Due to imdrf harmonization, the previously submitted method codes no longer apply to this event. 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: 7304161
• MDR Text Key: 101206971
• Report Number: 3004209178-2018-04208
• 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

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/28/2018 Patient Sequence Number: 1