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

Model Number 8637-20

Device Problems Fluid/Blood Leak (1250); Device Ingredient or Reagent Problem (2910)

Patient Problems Itching Sensation (1943); Muscular Rigidity (1968); Twitching (2172); Irritability (2421); Swelling/ Edema (4577)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_cath, lot# serial# unknown, product type catheter.Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was receiving baclofen (unknown concentration or dose) via an implantable pump for unknown indications for use.It was reported that the patient had a dye study on (b)(6) 2022 due to the patient having spasticity off and on (itchy, twitchy, irritable, and then feeling ok) for "a few months".The rep stated that they were able to aspirate from the cap (catheter access port) at the dye study but were concerned by the picture of the connector on the pump that looked a little "wonky" and not on the pump well.It was also noted that the fluid they pulled from the pump was a bit yellow tinged and the pump site got puffy from time to time.The radiologist was concerned that the fluid they pulled was from the pocket.Once the dye was injected, the dye was seen in the pocket which confirmed the poor connection issues.They plan to do a pocket revision likely in (b)(6).The patient will be managed with oral medication until then.It was theorized that where the cap was located could have been disturbed by the patient's hip bone.

• 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: 14571264
• MDR Text Key: 293279219
• Report Number: 3004209178-2022-07049
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2022
• Date Device Manufactured: 05/24/2018
• 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): Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male