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); Inappropriate or Unexpected Reset (2959)

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

Event Date 07/07/2017

Event Type  Injury  

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

Information was received from a foreign healthcare provider (hcp) via a manufacturer's representative regarding a patient who was receiving baclofen (unknown concentration and dose) via an implantable pump for an unknown indication for use.It was reported the pump was explanted and replaced on (b)(6) 2017 due to critical alarm status.The event date was not provided.The hcp asked the representative on 2017-jul-17 to return the pump for analysis; the pump was received on 2017-jul-18 by the representative.It was noted that only baclofen had been used in the pump.It was also noted that the representative had trouble communicating with the pump due to invalid telemetry.There were no reported symptoms.No further complications were reported or anticipated.Additional information was received.The patient was receiving baclofen 1,500 mcg/ml.The implant date was not known.The estimated elective replacement indicator (eri) was at 10 months.The pump would be returned the week of 2017-jul-24.The pump logs were received.When examined on (b)(6) 2017, the pump showed the messages "pump in safe state" and "reset occurred." it was noted that 15 pairs of "reset occurred" and "reset occurred - low battery" messages appeared, starting at 09:14 on (b)(6) 2017, until the last message at 09:28 on (b)(6) 2017.

Manufacturer Narrative

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

Event Description

Additional information was received.There were no identified contributing factors to the event.The patient was doing okay after pump replacement.The pump had been delivered through customer service in belgium on (b)(6) 2017 and would be returned the week of (b)(6) 2017.

Manufacturer Narrative

Analysis identified high resistance of the battery.Analysis identified corrosion and/or wear and/or lubrication issues of the gear train.Analysis identified stall due to shaft-bearing.Eval code-conclusion updated.Recent fda coding changes offer limited options for medical device evaluation conclusion coding.  medtronic selected conclusion code because, although the device meets design specification, medtronic made enhancements to the design making this the closest code available with respect to this event.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: 6740269
• MDR Text Key: 80915784
• Report Number: 3004209178-2017-15487
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2011
• 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