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

Model Number 8637-40

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Overdose (1988); Respiratory Distress (2045); Sedation (2368); Sweating (2444); Decreased Respiratory Rate (2485)

Event Type  Injury  

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id 8780 lot# serial# (b)(4) implanted: (b)(6) 2015 explanted: product type catheter.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 manufacturer representative regarding a patient who was receiving an unknown drug at an unknown concentration and dose via an implantable pump for non-malignant pain and chronic low back pain.It was reported that the patient had intermittent overdose symptoms.The healthcare provider (hcp) believed it might be catheter related.It was considered a sudden change in therapy/symptoms.The representative had no time to answer further questions.

Manufacturer Narrative

(b)(4).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

Additional information was received from the healthcare provider (hcp) and consumer through the manufacturing representative.The patient reported episodes of feeling like he was being overdosed.He suggested the catheter or maybe getting intermittently pinched.A catheter dye study and rotor study were conducted and found to be satisfactory.Additionally, the expected reservoir volume (erv) was compared to the actual reservoir volume (arv), and the volumes were accurate.The patient elected to have the pump removed.The removal was not yet scheduled.It was later reported that the patient stated he had three episodes where he thought he was experiencing overdose, typically following a bolus using his personal therapy manager (ptm).The last one was (b)(6) 2017.The previous episodes occurred in january (dates unknown).He went to the emergency room (er).However, the er doctor and the managing physician did not think it was related to the pump.The patient experienced sweating and respiratory depression.The pump was turned to minimum rate and would be explanted.Due to the change in therapy, the manufacturing representative was unsure if his episodes had occurred again.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 8780, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2017, product type: catheter.Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.(b)(4).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

Additional information was received from a manufacturer's representative on 2017-mar-07.The pump logs were read at the minimum rate; it was indicated that the pump was used to deliver fentanyl [2000.0 mcg/ml] at 12.4 mcg/day and bupivacaine [5.0 mg/ml} at 0.0310 mg/day.The returned product paperwork indicated that the daily dose was 150 mcg/day.It was reported that the issue began on (b)(6) 2017 and then was on-going; the patient experienced two episodes of overdose symptoms, shortness of breath, sedated, etc.The pump was used in the patient and intended for treatment.The pump was explanted on (b)(6) 2017 for therapy related reasons due to the overdose.It was indicated that no patient injury was reported, and the patient recovered without sequela.It was noted that a rotor study was preformed and the results were satisfactory; a dye study was also preformed and the results were satisfactory.No further complications were reported as a result of the event.

Manufacturer Narrative

Analysis of the pump found no anomaly.(b)(4).

Event Description

Additional information was received from the healthcare provider (hcp) on 04/19/2017 indicated the catheter had been disposed of.No further complications were reported/anticipated or expected.

Manufacturer Narrative

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.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6281318
• MDR Text Key: 65872264
• Report Number: 3004209178-2017-01835
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 111