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

Model Number 8637-40

Device Problems Infusion or Flow Problem (2964); Patient Device Interaction Problem (4001)

Patient Problems Muscular Rigidity (1968); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) and consumer via a company representative (rep) regarding a patient receiving baclofen (2000 mcg/ml at 2500 mcg/day) via an implantable infusion pump. The patient's medical history included idiopathic spasticity. It was reported that the patient was in office for end of service discussion for his pump. He stated that his spasticity had not been well controlled but could not pinpoint a specific time when it started. Troubleshooting indicated a catheter access port (cap) study was negative for flow and there was no flow at the time of surgery. It was also reported there was a good amount tissue at the pump connection portion of the catheter. It was unknown if there were any environmental, external, patient factors that may have led or contributed to the issue. The pump (normal elective replacement indicator (eri)) and catheter were replaced. The catheter was implanted on (b)(6) 2015 and was explanted on (b)(6) 2022 the patient¿s status at the time of this report was ¿alive, no injury". The patient's weight was asked at the time of the event but was unknown.

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2022, product type: catheter. Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 27-jul-2017, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

• 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: 14240590
• MDR Text Key: 290782759
• Report Number: 3004209178-2022-05398
• 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: Consumer,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/11/2015
• 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: 04/28/2022 Patient Sequence Number: 1