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

Model Number 8637-40

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2022

Event Type  malfunction  

Event Description

Information was received from multiple sources (manufacturer representative (rep), healthcare provider (hcp)) regarding a patient who was receiving baclofen (2000 mcg/ml at 240 mcg/day) via an implantable pump for intractable spasticity. It was reported that during a routine eri (elective replacement indicator) pump replacement, it came to the surgical team¿s attention that the catheter was severed. There were no known factors that may have led or contributed to the issue. The catheter was replaced and the issue was resolved at the time of report. The patient's medical history was asked but unknown. The patient's status at the time of report was alive, no injury.

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: 10-dec-2016, 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: 14138181
• MDR Text Key: 290068350
• Report Number: 3004209178-2022-04896
• 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: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/14/2016
• 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: 06/02/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial