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

Model Number 8637-40

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Distress (2329); Sedation (2368)

Event Date 01/28/2020

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 clinical study regarding a patient receiving hydromorphone 2. 5 mg for a total dose of 0. 86045 mg/day, bupivacaine 30 mg for a total dose of 10. 32541 mg/day, and compounded baclofen 150 mcg for a total dose of 51. 62704 mcg/day via an implantable pump. It was reported on (b)(6) 2020 the intrathecal (it) rate was increased secondary to increased pain following intrathecal rate decrease. On (b)(6) 2020 the patient came to the clinic with acute opioid withdrawal symptoms including emotional distress and severe pain. A catheter access port (cap) dye study was performed and revealed a normal functioning catheter. A pump malfunction was suspected. The patient was given hydromorphone 8 mg by mouth, ativan 1 mg by mouth, and clonidine 0. 1 mg by mouth. The it rate was decreased. The patient was monitored for 3 hours secondary to sedation. Pump replacement was ordered. The patient was started on a 25 mcg fentanyl patch, clonidine 0. 1 twice daily for withdrawal, and lorazepam daily as needed on (b)(6) 2020. On (b)(6) 2020 the pump was explanted/replaced. The outcome of the event resolved without sequelae on (b)(6) 2020. The device diagnosis was other suspected pump malfunction and the clinical diagnosis was it opioid withdrawal. The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related. The relatedness to the drug (hydromorphone, bupivacaine, and baclofen) was related and the drug action that caused the event was decreased dose. The event date was (b)(6) 2020. 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 9974560
• MDR Text Key: 188115301
• Report Number: 3004209178-2020-07347
• 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: health professional,study

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/17/2020 Patient Sequence Number: 1