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

Model Number 8637-40

Device Problems Occlusion Within Device (1423); Material Integrity Problem (2978)

Patient Problems Muscle Spasm(s) (1966); Muscular Rigidity (1968); Therapeutic Response, Decreased (2271)

Event Date 07/01/2012

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 8709, serial# (b)(4), implanted: (b)(6) 2012, product type catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was provided by a healthcare provider regarding an implantable intrathecal pump intended to deliver gablofen [2000 mcg/ml] in flex mode, with a daily dose of 332.6 mcg/day, indicated for intractable spasticity.It was reported that the patient's pump was replaced in (b)(6) 2012 and the patient did well initially with a reduction in her spasticity.[reference regulatory report #3004209178-2012-01536 for the manufacturer's report regarding the patient's previous pump.] it was reported that by (b)(6) 2012, she began having worsened spasms in her legs and back.She restarted oral baclofen to compensate.There was little improvement clinically with dose adjustments.In (b)(6) 2012,a nuclear medicine study demonstrated that she a had a non-functioning pump with occlusion at the level where the pump entered the spinal canal.The residual volumes were correct with her refills.On (b)(6) 2012, she had an exploratory surgery by a neurosurgeon.It was reported that they found a visible break in the catheter tubing and the catheter was repaired.The cause of the break was not determined.It was reported that per the clinical notes, "a clean break was identified." the location of the break was not determined.The patient experienced stiffness and spasticity related to the broken catheter.It was reported that the issue was resolved; an exploratory laparotomy and catheter replacement were performed as actions/interventions taken to resolve the catheter break.It was noted that the patient showed improvement foll owing the catheter revision on (b)(6) 2012.[reference regulatory report #3004209178-2018-01210 for the return of spasticity following the revision and catheter break that was identified on (b)(6) 2013.] the patient¿s medical history included le (lower extremity) spasticity secondary to a motor vehicle crash that occurred in 2003, that damaged her thoracic cord.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7322634
• MDR Text Key: 101833516
• Report Number: 3004209178-2018-04641
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 03/07/2018
• Date Device Manufactured: 01/25/2012
• 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: 28 YR
• Patient Weight: 82