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

Model Number 8637-40

Device Problems Failure to Interrogate (1332); Pumping Stopped (1503)

Patient Problems Therapeutic Response, Decreased (2271); Underdose (2542)

Event Date 11/06/2017

Event Type  Injury  

Event Description

Information was received from a healthcare provider via a company representative regarding a patient receiving bupivacaine, morphine, dose and concentrations not reported and baclofen 1000mcg/ml at 300mcg/day via an implantable pump.The indication for use was intractable spasticity.It was reported that a motor stall was seen at initial interrogation.The patient did not recently have an mri.The motor stall was active and the pump was being replaced.The patient was symptomatic with underdose and the patient had other health issues, including a trach in.Per the company representative he was currently in the or (operating room) and was not able to read the patient¿s implanted and alarming pump.The pump had a motor stall based on the code seen on the ptm (personal therapy manager) but stated that the home health nurse would not go out to read the pump, so the only indicator of the stall was the ptm (personal therapy manager).The company representative stated he could not interrogate the pump, he tired two different environments, tried turning off the or (operating room) lights and could interrogate the new pump in the same environment without issue.It was suspected that the motor stall occurred yesterday.No further complications were reported.

Manufacturer Narrative

Interrogation of the pump found that it was delivering 1000 mcg/ml baclofen at 395.5 mcg/day, 1.5 mg/ml morphine at 0.5537 mg/day, and 25 mg/ml bupivacaine at 9.887 mg/day.: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.Eval code-result 3233 now applies.Eval code-conclusion 92 updated to 11.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the rep on 2017-nov-07.The pump and catheter were returned to the manufacturer for analysis.There were no further complications reported/anticipated.

Manufacturer Narrative

Updated to reflect the information received on 2017-nov-08 (b)(4) added to reflect the information received on 2017-nov-08 if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on 2017-nov-08 from the healthcare provider (hcp) via a manufacturer's representative (rep).It was reported that the patient's pump was replaced and the patient was "doing as well as they could be".The rep noted that they had tried 3 different programmers and 2 different locations and were still not able to interrogate the patient's pump.It was noted that the patient was a "pretty sick patient" and has had pneumonia.The patient's hcp thought that the patient's symptoms can be associated with the pneumonia or the withdrawal.The rep noted that the patient had a trach so it was difficult to communicate with the patient.It was also noted that the patient had access to their own physician programmer, which was provided to the patient by their insurance.The rep reported that they would retrieve the programmer and send it back for analysis.The rep was concerned that this event may be related to the physician programmer or the software card and felt that the data from the programmer might be useful.The rep also noted that the patient's previous healthcare clinic "did not do a good job with the patient" and the patient was transitio ned to a clinic that was more "competent" to take care of the patient and the pump.Telemetry strips were also provided from the patient's new pump and from a pump interrogation session that occurred on (b)(6)2017.

Manufacturer Narrative

Analysis found that there was corrosion/wear/lubrication on the pump motor gear train and there was a stall due to shaft bearing on the pump motor gear train.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: 7008753
• MDR Text Key: 91298460
• Report Number: 3004209178-2017-23337
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2013
• 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: 56 YR