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

Model Number 8637-20

Device Problems Contamination (1120); Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id :8780, serial# : (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2021, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 10-dec-2016, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a company representative (rep) via a healthcare provider (hcp) regarding a patient with an implanted infusion pump receiving morphine and bupivacaine with a concentration of 20 mg/ml diluted to 5 mg/ml and 30 mg/ml diluted down to 7. 5 mg/ml with a dose of 0. 24mg/day and 0. 37 mg/day respectively. It was mentioned during normally scheduled pump replacement, due to nearing end of life of pump, the catheter could not be aspirated. Rep mentioned they tried to trim the pump segment to see if there was any flow from the intrathecal segment, and there was no flow. The healthcare provider (hcp) chose to replace the catheter. While he was connecting the new pump to the new catheter, the pump slid underneath the sterile drape and became contaminated. Therefore a new pump and pump segment needed to be opened and implanted. Patient status at the time of report was alive no injury. Issue was resolved at time of the report.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12619287
• MDR Text Key: 277151290
• Report Number: 3004209178-2021-15254
• 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,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2021
• 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: 10/12/2021 Patient Sequence Number: 1