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

Model Number 8637-40

Device Problems Fluid/Blood Leak (1250); Excess Flow or Over-Infusion (1311)

Patient Problem Insufficient Information (4580)

Event Date 12/20/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient receiving baclofen via an implanted pump.The indication for pump use was intractable spasticity.The patient reported via an email on (b)(6) 2021 that he had a follow-up visit with his physicians on (b)(6) 2021 after his pump exchange and based on their feedback an error occurred with the pump service.He stated that it was discovered and observed during the visit on (b)(6) 2021 that the baclofen in his replacement pump was less than half (18.5 volume) and its capacity was 40.Per the patient it was to be filled to 100 percent at the replacement procedure.The data from the pump scan now suggested a refill in early to (b)(6) 2022, about 4 months from now, and not the 6-7 months that he was expecting.He stated that he was greatly concerned on a number of counts.He stated he was ¿greatly concerned and troubled physically, psychologically, mechanically, medically, and financially/cost-wise¿.Additional information was received from the patient via a phone call on (b)(6) 2021 at which time he reported that he was told the pump was filled to capacity but only had 18 ml, so they were concerned that the pump was leaking.Per the patient, he only had the pump filled two times per year.He stated that he was working with his hcp (healthcare provider) to get resolution.

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient receiving baclofen via an implanted pump.The indication for pump use was intractable spasticity.The patient reported via an email on (b)(6) 2021 that he had a follow-up visit with his physicians on (b)(6) 2021 after his pump exchange and based on their feedback an error occurred with the pump service.He stated that it was discovered and observed during the visit on (b)(6) 2021 that the baclofen in his replacement pump was less than half (18.5 volume) and its capacity was 40.Per the patient it was to be filled to 100 percent at the replacement procedure.The data from the pump scan now suggested a refill in early to (b)(6) 2022, about 4 months from now, and not the 6-7 months that he was expecting.He stated that he was greatly concerned on a number of counts.He stated he was ¿greatly concerned and troubled physically, psychologically, mechanically, medically, and financially/cost-wise¿.Additional information was received from the patient via a phone call on (b)(6) 2021 at which time he reported that he was told the pump was filled to capacity but only had 18 ml, so they were concerned that the pump was leaking.Per the patient, he only had the pump filled two times per year.He stated that he was working with his hcp (healthcare provider) to get resolution.

• 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: 13107449
• MDR Text Key: 285482967
• Report Number: 3004209178-2021-19069
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000422615
• UDI-Public: 00763000422615
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2021
• Date Device Manufactured: 09/03/2021
• 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: 76 YR
• Patient Sex: Male