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

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Device Operates Differently Than Expected (2913)

Patient Problems Overdose (1988); Therapeutic Response, Decreased (2271); Sedation (2368); Confusion/ Disorientation (2553)

Event Date 05/21/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional (hcp) via manufacturer representative (rep) regarding a patient who was receiving dilaudid, unknown concentration at 0. 8 mg dose via intrathecal drug delivery pump for spinal pain. It was reported that it seemed pump delivered too much medicine. No environmental/external/patient factors that may have led or contributed to the issue were known. The hcp looked at logs and rechecked her calculations. Everything appeared normal. Patient was sent to emergency room and admitted to hospital. Electrocardiogram (ekg) was completed as well as other tests. Pump put in minimal rate. By this morning, patient was in withdrawal. Patient's pump was started back up this morning and patient went into an overdose situation. Pump was stopped and drug withdrawn and only 18cc in pump. They weren't sure what they were going to do. The rep was getting information over the phone- the hcp was aware of situation. They were trying to plan a course of action. Pump was stopped and empty. Surgical intervention did not happen and it was unknown if it was planned. At the time of this report, the issue was not resolved and patient status was alive-with injury, shortly after refill patient found by emergency medical response wondering in the hall of hospital and she was disoriented. No further complications were reported. The patient¿s medical history included some baseline confusion/dementia.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp). It was reported that the letter that they sent was incorrect in the sequence of events. No further complications were reported.

Manufacturer Narrative

Corrected information. 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 was received from a healthcare professional (hcp). It was reported that pump was refilled on (b)(6) 2018- dilaudid 5 mg/ml at a dose of 0. 5 mg/day. Within 5-10 minutes of the pump refill, the patient began to experience confusion and sedation. Rapid response involved and patient subsequently sent to emergency room for continued case. Pump turned to minimum rate (b)(6) 2018 around 7:20 pm. On (b)(6) 2018- reservoir assessed prevrealing 18 cc medication in the reservoir with expected volume
=
20ml. Medication removed from the reservoir and pump stopped. Patient continued to exhibit confusion with macular generation (amd) and required prolonged hospitalization. Patient was discharged from hospital on (b)(6) 2018. Patient was seen in office on (b)(6) 2018 and pump was turned off. The issue had been resolved. The cause of delivering too much medication was unknown-possible malfunction of internal tubing or occlusion rotors. No further complications were reported.

• 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: 7538165
• MDR Text Key: 109051886
• Report Number: 3004209178-2018-11673
• 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

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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/14/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/25/2016
• 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 Treatment Data

Date Received: 05/23/2018 Patient Sequence Number: 1