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

Model Number 8637-40

Device Problems Device Alarm System (1012); Intermittent Infusion (2341)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and healthcare provider (hcp) regarding a patient receiving baclofen(2000 mcg/ml, 1076.3 mcg/day) via an implantable infusion pump for the treatment of intractable spasticity.The pump implant was due to spinal cord injury.It was reported by the patient that the pump was beeping and was not consistent with pump alarms.The patient was discretion to follow up with healthcare provider (hcp) to have the pump checked.His low reservoir alarm date wasn't expected until (b)(6) 2018 and the patient did not have any adverse changes.No patient symptom was reported.Event date was (b)(6) 2018.Additional information was received from the healthcare provider (hcp) on the same day that multiple motor stalls and recoveries occurred.Logs revealed stall occurred on (b)(6) 2018 at 12:26 with a recovery on (b)(6) 2018 at 16:07.The pump stalled again on (b)(6) 2018 at 15:43 and recovered on (b)(6) 2018 at 00:14.Motor stalled occurred again at 12:52 on (b)(6) 2018.The patient did not have an magnetic resonance imaging recently.The patient was not in any new environments that could have caused stalls.The patient did not have itching or any spasms that the hcp was aware of.No further complication was reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer (con).It was reported that the patient was in the hospital an was waiting for an intrathecal baclofen pump emergency replacement.The pump was due for monday.The patient would like to speak to someone about getting it sooner, the patient's pump was shutting down.

• 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: 7641968
• MDR Text Key: 112556764
• Report Number: 3004209178-2018-14447
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2018
• Date Device Manufactured: 10/02/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR