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

Model Number 863740

Device Problem Material Integrity Problem (2978)

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial#: (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2009, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 14-may-2009, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving unknown baclofen (125 mcg/day) via an implanted pump.The indication for use was intractable spasticity and cerebral palsy.It was reported the patient was in several different rehab clinics and noted that they did not believe there was an issue with the baclofen, but the patient was having serious reactions.It was noted the catheter was cracked and started having the serious issues due to the cracked catheter.The patient was having interstitial absorption of the medication.It was noted the issue was about two years after the first pump was implanted.The caller stated that since the patient had become hypersensitive to the drug and stated the patient had never been able to be on that same dose since.On 2019-sep-12 lfc (hcp): additional information received from a healthcare provider reported the catheter was not cracked.The patient's weight was not known.The catheter was noted to be implanted and still running.Since the event date was unknown, we are unable to confirm if this hcp was managing the patient at the time of the cracked catheter.

• 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: 9078910
• MDR Text Key: 158981509
• Report Number: 3004209178-2019-17821
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2008
• Device Model Number: 863740
• Device Catalogue Number: 863740
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2019
• Date Device Manufactured: 05/15/2007
• 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