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

Model Number 8637-40

Device Problems Device Operates Differently Than Expected (2913); Protective Measures Problem (3015)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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 company representative (rep) regarding a patient receiving an unknown intrathecal medication via an implanted pump for non-malignant pain and other chronic/intract pain (trunk/limbs).The pump was returned and it was noted on the returned product paperwork there was a complaint associated with the device; however further information was not provided.

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

Additional information was reported by the company representative via a healthcare provider on 2017-mar-01.It was reported that the patient had experienced symptoms of withdrawal and increased pain.The pump had been read on (b)(6) 2016 which showed the pump had gone into safe state.The patient was admitted for pain control and the pump was programmed to minimum rate.It was noted that the pump had been replaced and there were no other known complaints; no further complications were reported.

Manufacturer Narrative

Analysis of the pump found battery high resistance.Interrogation of the device revealed it contained dilaudid.(b)(4) is no longer applicable.(b)(4) is being updated to (b)(4) for this event.Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected (b)(4) because, although the device meets design specification, medtronic made enhancements to the design making this the closest code available with respect to this event.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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6325654
• MDR Text Key: 67244762
• Report Number: 3004209178-2017-03681
• 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: company representative,health
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2011
• 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/Z-2276-2009
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention