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

Model Number 8637-40

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cognitive Changes (2551)

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: a810, product type: software.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare provider (hcp) via a company representative (rep) indicated the patient¿s weight at the time of the event was unknown.It was noted it seemed to be a simple decimal point error.The reporter was not at the case and got involved the next day post operative and noticed the error, due to the refill date being in three days.The new tablet was being used at the time of the event.No further complications were reported/anticipated or expected.

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_prog, serial# unknown, product type: programmer, physician.Other relevant device(s) are: product id: neu_unknown_prog, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a company representative (rep) regarding a patient receiving intrathecal unknown morphine 1.3 mg/ml at 1.8 mg/day via an implanted pump for non-malignant pain and chronic low back pain.It was reported the drug dose was entered incorrectly and the patient¿s pump was incorrectly programmed during the time of the implant on (b)(6) 2018.The dose was programmed to 1.8 mg/day and was supposed to be 0.18 mg/day.The rep was with the patient to update the pump back to the correct 0.18 mg/day (resolved).It was noted the patient had low blood pressure (no intervention) and was feeling groggy (potentially from surgery on (b)(6) 2018).Troubleshooting resolved the reported issue.The rep was also walked through how to resync the new ptm to the patient¿s pump after an error dose was changed to the correct dose and the ptm was able to be resynched.No further complications were reported/anticipated or expected.

• 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: 8038600
• MDR Text Key: 126282332
• Report Number: 3004209178-2018-24680
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2018
• Date Device Manufactured: 09/04/2018
• 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 Age: 68 YR