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

Model Number 8637-20

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 11/10/2021

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 patient who was receiving dilaudid (hydromorphone) (unk mg/ml at 1 mg/day) via an implantable pump for non-malignant pain.It was reported that the patient had a fall on her back about two weeks ago and now she "could not hardly walk." the patient was worried that there might be something wrong with the pump and she had a bump on her back.The patient had been very active since the implant and does a lot of bending.It was noted the patient had pain when she bends over and her thoracic back was hurting.The patient was seeing the doctor on (b)(6) 2021.It was advised to discuss with her hcp what level of activity is appropriate.Reviewed typical healing time from implant.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.

• 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: 12990042
• MDR Text Key: 287240675
• Report Number: 3004209178-2021-18477
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000422608
• UDI-Public: 00763000422608
• 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: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2021
• Date Device Manufactured: 09/30/2021
• 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: 73 YR
• Patient Sex: Female