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)

Patient Problems Overdose (1988); Sedation (2368); No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2017

Event Type  malfunction  

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

Information was received from a healthcare professional via manufacturer representative regarding a patient who was receiving bupivacaine (5 mg/ml, 1.9136 mg/day) and morphine (unknown) (2 mg/ml, 0.7654 mg/day) via intrathecal drug delivery pump for non-malignant pain and rsd (reflex sympathetic dystrophy)/causalgia (complex regional pain syndrome).It was reported that a motor stall was seen at initial interrogation, the patient did not recently have an mri (magnetic resonance imaging).The pump status and/or event log reported "motor stall occurred" and "motor stall (active)." the tss (technical service specialist) reviewed the following motor stall considerations with the reporter: consider pump replacement.The reporter stated that the pump would be replaced but that she did not have a date.The tss reviewed with the reporter to send the pump back for analysis after explant.There were no reported symptoms.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer's representative on (b)(6) 2017.It was reported that there were multiple motor stalls and recoveries.It was confirmed that the original motor stall recovered and the logs showed a series of motor stalls and motor stall recoveries.It was indicated that they were replacing the pump the date of the report (b)(6) 2017, and that the pump would be sent back for analysis.It was noted that the patient was acting like they were ¿over-medicated¿ and was sedated.It was indicated that it was confirmed that the patient would get the full dose from the pump at the times it was not stalled.No further complications were reported or anticipated.

Manufacturer Narrative

Evaluation of implantable pump serial number (b)(4) revealed residue in the motor gear train and wearing on the upper and lower shaft of gear number two.Eval code-result and eval code-conclusion are no longer applicable.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 the health care professional via the manufacturer¿s representative indicated that the pump was returned to the manufacturer earlier on the week of (b)(6).No further complications were anticipated/reported.

Manufacturer Narrative

Correction: malfunction was previously checked in error.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the company representative (rep) and additional notes on the returned paperwork indicated " abdominal wall tissue exam on (b)(6) 2017 pain pump and cath.".

• 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: 6871571
• MDR Text Key: 86417491
• Report Number: 3004209178-2017-19482
• 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: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2013
• 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: 50 YR