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

Model Number 8637-20

Device Problems Difficult to Interrogate (1331); Pumping Stopped (1503); Battery Problem (2885)

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

Event Date 12/21/2014

Event Type  Injury  

Event Description

The patient also had increasing discomfort, pain, and was in mild distress related to the event.On (b)(6) 2014, prior to the pump replacement procedure, the patient was given some oral baclofen and iv (intravenous) morphine to stabilize him.After the pump replacement, the patient recovered without permanent impairment.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient began to have withdrawal symptoms on a weekend.These included increased spasticity/spasms, profuse sweating/diaphoresis, nausea, and underdose symptoms.The location of symptoms was noted as the whole body with dramatic spasticity in the legs.The patient was seen on a monday by an infusion representative who realized the pump was in a motor stall and was having problems maintaining telemetry.The representative contacted the physician who recommended an immediate explant and replacement.It was also reported that there was a pump failure as a critical alarm occurred.A motor stall which did not recover and battery depletion/unknown was also reported.The logs indicated that a motor stall occurred on (b)(6) 2014 at 21:47 with a stopped pump period may exceed tube set on (b)(6) 2014 at 21:47.It was unknown if any diagnostic testing or troubleshooting occurred but the alarms were silenced.The cause of the issue was not determined but the issue was reported as resolved which required surgical intervention.The patient lived in a care center.He was transported through the emergency room and admitted for surgery.The patient was given narcotics and the pump was explanted and replaced without difficulty.The catheter was intact with good back flow.The patient¿s does was resumed on the previous flow rate since it was determined he had not been without it long enough to need titration.At the time of the report the patient's status was reported as alive-no injury.This device system delivered baclofen and morphine.Additional information was requested to verify the patient¿s current status.Should additional information be received a supplemental report will be filed.

Manufacturer Narrative

Concomitant medical products: product id 8711, lot# j11361r40, implanted: (b)(6) 2003, product type: catheter.(b)(4).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Analysis of the pump revealed pump motor gear train anomaly, corrosion and or wear and or lubrication, stall due to shaft-bearing.

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): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4404314
• MDR Text Key: 5314313
• Report Number: 3004209178-2015-00448
• 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,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2009
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2008
• 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: 00052 YR
• Patient Weight: 54