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

Model Number	8637-20
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2017, 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 or Problem Description
Information was received from a health care provider (hcp) via a manufacturer representative regarding a patient with an implantable drug infusion pump indicated for non-malignant pain.The pump contained fentanyl with a concentration of 50 mcg/ml at a dose of 25 mcg/day.It was reported the patient started experiencing severe pain after surgery.The hcp opened the back incision and pulled down the catheter.When the patient awoke from surgery, she stated her pain was considerably better.It was unknown what environmental/external/patient factors that might have led or contributed to the issue.It was unknown what diagnostics/troubleshooting was performed.The only intervention was catheter revision.It was unknown if the issue was resolved at the time of the report.Additional information received from the representative on 2017-feb-16 reported a nurse practitioner told them what was going on when they showed up to cover the case.The doctor thought the catheter might have been bumping a nerve.The representative had not heard anything else regarding the patient.The patient status at the time of the report was alive ¿ no injury.
Event or Problem Description
Additional information received from the representative reported they were not aware the cause of the catheter bumping a nerve had been determined.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYNCHROMED II
• Common Device Name: 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
• MDR Report Key: 6342373
• Report Number: 3004209178-2017-04150
• Device Sequence Number: 16351225
• Product Code: LKK
• UDI-Device Identifier: 00643169202122
• UDI-Public: 00643169202122
• Combination Product (Y/N): N
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided; 02/18/2017
• Initial Report FDA Received Date: 02/18/2017
• Supplement Report FDA Received Date: 02/19/2017; 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR