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

Model Number 8637-20

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 04/15/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial# (b)(4), implanted: (b)(6) 2015, product type: catheter.Analysis of the implantable infusion pump (s/n (b)(4)) found overinfusion of an undetermined root cause.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care provider (hcp) regarding a patient receiving fentanyl (200 mcg/ml at 39.99 mcg/day) and clonidine (40 mcg/ml at 7.997 mcg/day) via an implantable infusion pump.The indication for use was noted to be degenerative disc disease.It was reported that the patient was last seen in the doctor's office on (b)(6) 2018.They were turning down the patient's pump per the patient's request as they wanted to terminate therapy.The patient was not getting the relief desired.The patient had no other symptoms.No other information was provided or known.The pump was explanted on (b)(6) 2018 and returned to the manufacturer for analysis.No further complications were reported.

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): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7726926
• MDR Text Key: 115470303
• Report Number: 3004209178-2018-16834
• Device Sequence Number: 0
• Product Code: LKK
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2015
• 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): Other
• Patient Age: 67 YR