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

Model Number 8637-20

Device Problem Infusion or Flow Problem (2964)

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

Event Date 03/05/2022

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant medical products: product id 8709, lot# j11176r58, serial# (b)(4), implanted:(b)(6) 2002, product type: catheter , ubd: 22-apr-2004, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2022, information was received from two healthcare professionals (hcp), via a manufacturer representative (rep), regarding a patient receiving gablofen (2,000 mcg/ml, 300 mcg/day) via an implantable pump. The patient's other medications were methylphenidate, tegretol, lexapro, baclofen prn. The patient's medical history includes; traumatic brain injury with spastic quadriparesis, nystagmus, myopia, exposure keratopathy left, and dysarthria, suspension, vision impairment, posttraumatic hydrocephalus, wheelchair-bound, itb pump. It was reported the patient was originally implanted at another clinic and started to be managed by another clinic in (b)(6) 2021. The patient was scheduled for pump expected ended of life battery replacement. Routine access to the catheter access port (cap) was done in anticipation and upon replacement and the clinician was unable to withdraw cerebrospinal fluid (csf) back from the cap on (b)(6) 2022. The patient never exhibited any signs or symptoms of baclofen withdrawal nor loss of therapy efficacy. A catheter exploration and pump replacement was scheduled for (b)(6) 2022. The issue was not resolved at the time of this report. Additional information reported the pump has been refilled four times since the new clinic started managing the pump. The expected versus residual volumes were accurate at these four refills.

• 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: 14219918
• MDR Text Key: 290170718
• Report Number: 3004209178-2022-05319
• 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: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/14/2017
• 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: 04/27/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 02/25/2016
• 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: 04/27/2022 Patient Sequence Number: 1