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

Model Number 8637-20

Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2002, explanted: (b)(6) 2022, product type: catheter. Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 09-may-2004, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from an healthcare provider (hcp) via company representative (rep) regarding a patient who was receiving morphine (10 mg/ml at 0. 48 mg/day) via an implantable pump for non-malignant pain, failed back surgery syndrome, unsuccessful disc surgery, and spinal pain indications. It was reported that the patient had loss of therapy and their pump flipped. Contributing factors included patient compliance. The physician made an incision of the pump pocket and noted the catheter was twisted upon itself and completely broken. The catheter was replacement on (b)(6) 2022. The issue was resolved at the time of report. The patient's medical history were asked but unknown. The patient's status at the time of report was alive - no injury.

• 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: 13891442
• MDR Text Key: 287844223
• Report Number: 3004209178-2022-03709
• 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
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 09/27/2021
• 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: 03/24/2022 Patient Sequence Number: 1