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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Fever (1858); Vomiting (2144); Chills (2191)

Event Date 12/10/2021

Event Type  Injury  

Event Description

Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving bupivacaine via an implantable pump. It was reported the patient was bedridden for 2 days with stomach aches, chills, and fever on (b)(6) 2021. On (b)(6) 2021, the patient reported hospital admission due to withdrawal-like symptoms. On (b)(6) 2021, the patient visited the er for withdrawal-like symptoms: excessive drowsiness, severe stomach pain, vomiting, increased abdomen pain and low grade fever. Requested pump explant. It was indicated the event was possibly related to the device or therapy and related to the bupivacaine. No actions were taken and the event was ongoing.

Manufacturer Narrative

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

• 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: 13159077
• MDR Text Key: 285841087
• Report Number: 3004209178-2022-00087
• 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: Study,Health Professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/14/2022
• 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: 02/05/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 10/26/2020
• 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: 01/04/2022 Patient Sequence Number: 1