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

Model Number 8637-40

Device Problems Excess Flow or Over-Infusion (1311); Volume Accuracy Problem (1675); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Overdose (1988); Respiratory Distress (2045); Sedation (2368); Decreased Respiratory Rate (2485)

Event Date 11/23/2017

Event Type  Injury  

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer's representative regarding a patient who was receiving morphine [10 mg/ml] at a dose of 6.7 mg/day via an implantable pump for non-malignant pain and lumbar radiculopathy.It was reported on (b)(6) 2017 that the patient was admitted for respiratory depression and the hcp called orders to reduce the pump from 6.7 to 3.5 mg/day of morphine.The patient was alert and oriented at the time.The date of the event was (b)(6) 2017.There were no environmental/external/patient factors that may have led or contributed to the issue.At the time of the report the issue was not resolved, and the patient status was ¿alive ¿ no injury¿ (note this is conflicting with the report of respiratory depression).Surgical intervention did not occur and was not planned.(b)(6).The patient¿s medical history included diabetes type ii and osteoporosis.Other medications that the patient was taking at the time of the event included gabapentin 300 2 x 4 times a day, paroxetine 40 mg/day, ranitidine 150 mg twice a day, aspirin 81 mg, calcium 600 mcg/day, simvastatin 20 mg/day, and magnesium 400 mg/day.Additional information was received on (b)(6) 2017.It was reported that the patient¿s husband reported that the patient had just recently called the manufacturer and got a new personal therapy manager (ptm).The patient¿s husband also reported that the patient was using the ptm every four hours and that was when the patient seemed more sedated.The hcp also ordered the ptm to be disabled which was done that day as well.It was stated that no further information was available at the time of the report.Additional information was received from a healthcare professional (hcp) via a manufacturer's representative on (b)(6) 2017.It was reported that they were unsure if the respiratory depression and sedation were suspected to be related to the device/therapy and noted that the patient awoke after four doses of narcan.There were not any events leading up to the respiratory depression and sedation.It was stated ¿n/a¿ in response to if the cause of the respiratory depression and sedation was determined.It was indicated that the provided information had been confirmed with the physician/account as the manufacturer's representative spoke to the hcp about the patient on (b)(6) 2017.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider via a manufacturer's representative on 2018-mar-28.It was reported that the patient stated at her appointment on (b)(6)2018 that she feels the pump caused her hospitalization, because she woke after narcan.The patient stated that she was now going to a new healthcare provider in (b)(6), and was going to have her pump removed, and wants it back to be analyzed.No further information was available at the time of the report.

Manufacturer Narrative

The previously applied device code (b)(4) was replaced with (b)(4) and (b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: only adverse event was previously indicated.Updated to include both adverse event and product problem.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider via a company representative.The patient was scheduled for explant today (b)(6) 2018.It was noted that the company representative was notified by the physician that this was a legal case.The physician showed the company representative a letter from the patient¿s attorney advising the pump to be preserved for the patient to obtain after the pump was explanted.It was noted that the company representative was not to take the pump into their possession.The pump was to be returned to the patient per legal letter from an attorney that was presented to the company representative.It was further noted that the physician recommended the company representative not interrogate the patient¿s pump or be present in the operating room at all.Notes from the pain pump reprogram obtained at refill were provided.At the september refill the expected residual volume (erv) was 10.3 and the actual residual volume (arv) was 12 ml.At the (b)(6) refill the erv was 15 ml and the arv was 16 ml.At the (b)(6) refill the erv was 6.5 ml and the arv pulled out by the physician was 7 ml.

Manufacturer Narrative

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

Event Description

Additional information received from a consumer via the legal team reported the patient sustained injuries due to the use of the pump and morphine overdose incident caused by the pump that occurred on (b)(6) 2017, resulting in hospitalization.The patient discontinued use of the pump and was scheduled to have the pump removed on (b)(6) 2018.

Manufacturer Narrative

Analysis of the pump identified no anomalies.(b)(4) no longer applies.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: 7062731
• MDR Text Key: 93041699
• Report Number: 3004209178-2017-24420
• 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,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2012
• 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-1570-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 76