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

Model Number 8637-40

Device Problems Premature Elective Replacement Indicator (1483); Pumping Stopped (1503); Intermittent Infusion (2341)

Patient Problems Muscular Rigidity (1968); Vomiting (2144)

Event Date 05/12/2017

Event Type  Injury  

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer's representative (rep) regarding a patient receiving 2,000 mcg/ml lioresal at a dose of 1,205 mcg/day via an implantable infusion pump for intractable spasticity and multiple sclerosis.It was reported that a motor stall was seen at initial interrogation and the patient had not recently had an mri.The pump logs revealed a stall lasting almost two days on (b)(6) 2017 and an active stall starting at 01:23 on (b)(6) 2017.The patient was in the emergency room with symptoms of vomiting and an increase in tone.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer's representative (rep).It was reported that the pump was reduced to minimum rate and scheduled for replacement which occurred on (b)(6) 2017.The cause of the stall remains unknown.The patient weight was unknown.The pump would be returned for analysis.No further complications were anticipated/reported.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.The previously applied device code (b)(4) was replaced with (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received via a company representative.The pump was returned to the manufacturer.As per the pump¿s log the following occurred: a motor stall on (b)(6)2017 at 06:46, a stopped pump period may exceed tube set message on (b)(6)2017 at 06:46, a motor stall recovery on (b)(6)2017 at 09:15, a motor stall on (b)(6)2017 at 01:39, a stopped pump period may exceed tube set message on (b)(6)2017 at 01:39, a motor stall recovery on (b)(6)2017 at 20:48, a motor stall on (b)(6)2017 at 20:31 (post explant), a motor stall recovery on (b)(6)2017 at 07:00, a motor stall on (b)(6)2017 at 02:53, and a motor stall recovery on (b)(6)2017 at 11:28.Also per the pump¿s log, elective replacement indicator (eri) had occurred on (b)(6)2017.No dye study or rotor study was performed.

Manufacturer Narrative

The pump was returned for analysis.Pump analysis found gear train anomalies of stall due to shaft bearing and corrosion, wear or lubrication.Additionally, high resistance across the battery was found.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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

• 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: 6623040
• MDR Text Key: 77027433
• Report Number: 3004209178-2017-11909
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-3043-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR