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

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Muscle Spasm(s) (1966); Pain (1994); Tachycardia (2095); Ventricular Fibrillation (2130); Toxicity (2333); Loss Of Pulse (2562)

Event Date 12/08/2016

Event Type  Death  

Manufacturer Narrative

The pump was returned for analysis. Analysis identified overinfusion due to an undetermined root cause and residue on the gear shaft of the motor gear train that resulted in the motor stall. If information is provided in the future, a supplemental report will be issued.

Event Description

Device returned with no return paperwork. The pump was returned to the manufacturer without a complaint. No patient symptoms or complication were reported as a result of this event. Additional information was received from a healthcare provider (hcp) indicated that the patient had dies due to multifactorial causes which included possible baclofen toxicity. No autopsy was performed. On (b)(6) 2016, the patient was seen by their pump physician for a pump refill and there were no issues with volume discrepancies or issues observed in the logs upon pump interrogation. On (b)(6) 2016, the patient returned to their pump physician due to increased spasms that were increasing in intensity. The pump was increased 5% at that time, but it did not help and spasms continued; the pump was infusing baclofen and morphine at that time. The patient went in to the emergency department on (b)(6) 2016 and was treated with intravenous morphine for pain and oral baclofen and valium for their spasms. The patient subsequently dropped their blood pressure and was treated with vasopressin and epinephrine. At some point, the patient was admitted to the icu. The patient lost their pulse, went into ventricular tachycardia and ventricular fibrillation. The hcp stated that there was no information provided to suggest that it was due to the pump. The patient was defibrillated several times, but passed away on (b)(6) 2016. The hcp again stated that there was nothing in the patient chart to indicate that there was a problem with the pump, but did state that one possible cause of death was possible baclofen toxicity. No additional information was provided.

Manufacturer Narrative

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: 7731465
• Report Number: 3004209178-2018-16914
• Device Sequence Number: 0
• 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: health professional,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• 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: 05/22/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 57 YR
• Patient Outcome(s): Death; Hospitalization; Life Threatening