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

Model Number 8637-20

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

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Cognitive Changes (2551); Insufficient Information (4580)

Event Date 09/01/2021

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 provider (hcp) and a company representative regarding a patient receiving duramorph (5 mg/ml at 0. 7304 mg/day) and marcaine (27. 6 mg/ml at 4. 032 mg/day) via an implanted pump. The indication for pump use was non-malignant pain. It was reported by the nurse practitioner that the patient was hospitalized today with hypotension, bradycardia, and was obtunded. The reporter believed the patient was getting too much intrathecal medication and they wanted the dose decreased. Per the reporter, the patient was seen 1 month ago at the hospital with similar symptoms, but not as significant and at that time they felt his dosing was too high and they discontinued his chlorthalidone. The patient had been routinely going in for dosing increases. Per the reporter, the patient took a lot of antidepressants, was also using ativan 0. 5 mg, and was on lasix. The emergency overdose procedure and emptying the reservoir were discussed and the reporter stated that theywould prefer to program the pump to a lower dose. Additional information was received from a company representative who reported that he was called to go to the icu (intensive care unit) because the patient needed his pump turned down. Per the reporter, he was in the hospital for other medical conditions. It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue. The pump dose was decreased by 15% per the physician. It was unknown if the issue was resolved, and it was indicated that the hcp had no further information to provide regarding the event.

• 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: 12728225
• MDR Text Key: 279287985
• Report Number: 3004209178-2021-16201
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/17/2021
• 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: 11/01/2021 Patient Sequence Number: 1