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

Model Number 8637-40

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

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

Event Date 12/04/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8598a, serial#: (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: product id: 8598a, serial/lot #: (b)(4), ubd: 05-may-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving compounded baclofen (unknown dose and concentration), hydromorphone (unknown dose and concentration), bupivacaine (unknown dose and concentration), and clonidine (unknown dose and concentration) via an implantable pump.It was reported on (b)(6) 2021 the hcp received a message that the patient reported an new pain (onset (b)(6) 2021) in their spine resulting in immobility.The patient described the pain as grinding.After contacting emt, the patient was transferred to the ed (emergency department) where a ct (computed tomography) scan was unremarkable.The pain had since subsided but returns intermittently.The patient was scheduled for a next-day office visit.On (b)(6) 2021 it was noted the pain worsens when sitting or standing; but improves when supine.The patient was started on percocet, administered a toradol injection, and an mri (magnetic resonance imaging) was ordered.On (b)(6) 2021 a cap (catheter access port) dye study revealed the catheter migrated from t3 to t10 dorsal, left of midline.It was also coiled near the cap port in the right flank, likely causing the acute pain.The plan was for a catheter revision.It was noted that minimal csf (cerebrospinal fluid) was aspirated.On (b)(6) 2022 surgical intervention occurred where the catheter was spliced and the spinal segment was replaced and tip positioned at t4.The outcome of the event resolved without sequelae on (b)(6) 2022.The device diagnosis was other catheter coiled neat catheter access port and catheter dislodgement.The clinical diagnosis was new region/quality of pain in spine.The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.

• 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: 13258160
• MDR Text Key: 284168301
• Report Number: 3004209178-2022-00649
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• 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: 01/11/2022
• Date Device Manufactured: 04/06/2017
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 68 KG