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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Volume Accuracy Problem (1675)

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

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

References the main component of the device system; the other relevant components include: product id: 8703w, lot# l46991, implanted: (b)(6) 1997, product type: catheter.Product id: 8781, serial# (b)(4), implanted: (b)(6) 2012, product type: catheter.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 healthcare provider (hcp) regarding a patient who was receiving fentanyl 300 mcg/ml; 43.05 mcg/day and bupivacaine 15 mg/ml; 2.153 mg/day via an implantable pump.Indication for use was non-malignant pain and failed back surgery syndrome.The date of the event was approximately (b)(6) 2017.It was reported the pump had a volume discrepancy.The actual residual volume (arv) was greater than the expected residual volume (erv) since (b)(6) 2017.A catheter access port (cap) study was done and the catheter was occluded.The patient needs a catheter revision.No symptoms reported.No further complications were reported.

Manufacturer Narrative

Correction /update: added device code for catheter.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Patient code (b)(4) is no longer applicable to the event.Medtronic if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp).The patient experienced decreased pain relief.A side port study could not be accessed on (b)(6) 2017 after several attempts.On (b)(6) 2018 the expected residual volume was 8 ml; the actual residual volume was 10 ml.Elective replacement indicator (eri) was 19 months.The cause of the volume discrepancy and catheter occlusion was not determined.An order was submitted to workers compensation to replace the pump and catheter.The volume discrepancy and catheter occlusion have not been resolved.The patient¿s weight at the time of the event was 245 pounds.Medical history includes hypertension (htn), hyperlipidemia, type ii diabetes, lumbar radiculitis, lumbar sprain/strain, chronic pain syndrome, and post laminectomy syndrome.

• 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: 7220689
• MDR Text Key: 98277920
• Report Number: 3004209178-2018-01415
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 01/25/2018
• Supplement Dates Manufacturer Received: 01/24/2018; 02/15/2018
• Supplement Dates FDA Received: 01/26/2018; 02/19/2018
• Date Device Manufactured: 10/08/2012
• 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
• Patient Age: 64 YR
• Patient Weight: 111