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

Model Number 8637-20

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182)

Patient Problems Bradycardia (1751); Fatigue (1849); Low Blood Pressure/ Hypotension (1914)

Event Date 04/01/2019

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 a company representative regarding a patient who was receiving clonidine 200 mcg/day (unknown concentration) via an implantable pump. Indication for use was non-malignant pain. The date of the event was approximately (b)(6) 2019. It was reported the patient was approximately two weeks late for a pump refill. The patient followed up at the hcp office on (b)(6) 2019 for a pump refill. The hcp attempted to refill the pump and had to stick the patient several times. The hcp felt like he had the needle in the reservoir. The hcp was unable to pull any fluid back, as the pump was dry. The hcp pushed the drug in and attempted to pull back during the refill a couple of times, 5 cc each and the drug did come back. The hcp continued to feel like he was in the reservoir. After filling the pump, the hcp pulled the needle out and again, felt like it had been in reservoir. The pump was programmed. The patient left the building and as she got into parking lot, started to feel tired. The patient went back to the hcp office. The patient¿s blood pressure and heart rate were low. At that time, it was believed that the pocket was filled and not the pump. Factors that may have led to the issue was the patient was obese, no weight given. An ambulance was called. The patient was transported to the hospital but did not have to be incubated. The patient was ¿doing okay¿ on (b)(6) 2019. The issue was resolved. Patient status was alive - no injury. Patient weight and medical history were asked and will not be made available. 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: 8594774
• MDR Text Key: 144540676
• Report Number: 3004209178-2019-09221
• 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: Notification
• Type of Report: Initial
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/14/2019
• 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: 05/08/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/16/2017
• 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-1060-2011

Patient Treatment Data

Date Received: 05/09/2019 Patient Sequence Number: 1