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 Low Blood Pressure/ Hypotension (1914); Decreased Respiratory Rate (2485); Lethargy (2560)

Event Date 08/01/2021

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 manufacturer's representative (rep) via a healthcare provider (hcp) regarding a patient with a implantable infusion pump with lioresal (baclofen) concentration 2000 mcg/ml is and dose is 417.5 mcg/day for intractable spasticity.It was reported that the reason for call was for assistance with decreasing a patient's flex dose.The rep stated that the patient is in icu and conference on the icu hcp who is ordering the decrease in the 24 hours dose.The icu physician states that he would like a 15% deduction of the basal rate from 12.4 mcg to 10.5 mcg and a 30% decrease for each step.The patient has three steps at 4 am, 12 pm, and 9 pm that are all 4 minutes and are a dose of 79.9 mcg within 4 minutes.Technical services confirmed that he would like each step to drop to 55.9 mcg and he agreed.The icu hcp ordered this decrease because the patient has been in icu with decrease respirations, decreased blood pressure, decreased respiratory rate, lethargic, and sleeping.The icu physician states that the patient's symptoms occur at near when the flex boluses are administered at 4 am, 12 pm, and 9 pm, so he suspects once they decrease the flex dose that her symptoms will alleviate.24 hour dose went from 534.8 mcg/day to 417.6 mcg/day.Technical services assisted them in programming these changes.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12284806
• MDR Text Key: 265379329
• Report Number: 3004209178-2021-11984
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2021
• Date Device Manufactured: 11/14/2019
• 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): Hospitalization; Life Threatening
• Patient Age: 74 YR
• Patient Weight: 67