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 Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); Sleep Dysfunction (2517)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the consumer via a device manufacturer representative regarding a patient receiving baclofen (2000 mcg/ml at 170.8 mcg/day) via an implantable infusion pump.It was reported that post replacement surgery the patient had some spasticity and trouble sleeping.The patient's mother was concerned that her he may be having withdrawals.The issue was unresolved and the patient was alive with no injury.No further complications have been reported as a result of this event.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event no longer meets the reporting requirements stipulated in 21 cfr 803.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative on 2020-feb-06.It was reported that the hcp talked to the mother of the patient and told her to supplement baclofen orally.The symptoms subsided and the pump was functioning normally.

• 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: 9644140
• MDR Text Key: 185671472
• Report Number: 3004209178-2020-02132
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2020
• Date Device Manufactured: 09/23/2019
• 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 Outcome(s): Other
• Patient Age: 35 YR