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

Model Number 8637-20

Device Problem Pumping Stopped (1503)

Patient Problems Dyspnea (1816); Therapeutic Response, Decreased (2271); Anxiety (2328); Sweating (2444)

Event Date 04/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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

On (b)(6) 2017, information was received from a foreign healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving baclofen (2000 mcg/ml, 1000 mcg/day) via an implantable pump for an unknown indication for use.On (b)(6) 2017, the pump stopped working 15 months before elective replacement indicator (eri).The pump gave a critical alarm for about 3 hours and it was stated, "the pump doesn't start working during this period" (also reported as motor stop).A pump replacement occurred on (b)(6) 2017, reported as a partial explant, before the patient "get further withdrawal symptoms".The status of the patient was stated to be alive and with no injury.The event was considered to be resolved as of (b)(6) 2017.No further complications were reported/expected.

Manufacturer Narrative

(b)(4).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

On 2017-apr-25, additional information was received from a foreign manufacturer representative (rep).It was confirmed the pump was explanted on (b)(6) 2017.The critical alarm first occurred on (b)(6) 2017.The previous statement "the pump gave a critical alarm for about 3 hours" was clarified that the alarm began in the morning and still persisted until the pump explanation.It was also reported that after 3 hours of the pump alarming, the patient first got withdrawal symptoms, specifically shortness of breath, nervousness and sweats.When the patient first got their withdrawal symptoms, a pump replacement was "arranged immediately".Clarification to "pump stops working 15 months before eri" was attempted and it was stated, "it only means that the motor stopped".It was reported the patient was doing well again.

Manufacturer Narrative

Analysis of the pump (sn; (b)(4)) found motor gear train anomalies; corrosion and/or wear and/or lubrication and the stall was due to shaft-bearing.Analysis identified residue in the motor gear train that contributed to the motor stall.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.

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.

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: 6501491
• MDR Text Key: 73092937
• Report Number: 3004209178-2017-08542
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2011
• 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