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

Model Number	8637-20
Medical Device Problem Codes	Occlusion Within Device (1423); Aspiration Issue (2883); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)
Date of Event	01/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d information references the main component of the system and other applicable components are: product id 8780 lot# serial# (b)(4) implanted: (b)(6) 2015 explanted: 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 healthcare provider (hcp) via a manufacturer representative regarding a patient who was receiving 25 mg/ml dilaudid at a dose of 1.2 mg/day via an implantable pump for spinal pain.It was reported that the patient experienced their pain symptoms return.The hcp was unable to aspirate the catheter in their office on an unknown date, so a catheter revision was scheduled.There were no known environmental, external, or patient factors that may have led or contributed to the event.The catheter revision was performed on (b)(6) 2017.The pump segment of the catheter was revised.There was good cerebrospinal fluid (csf) flow observed.The issue was resolved at the time of the report and the patient status was alive with no injury.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Additional information was received from a consumer.It was noted that the dose of the dilaudid was ¿6.5¿ with units unknown.It was reported on (b)(6) 2017 that the patient had a pump where the line had become blocked.It was noted that for about six months the patient experienced trouble with significant amount of pain until the point of it being unbearable and then they decided to replace the catheter on (b)(6) 2017 (note the verbatim "replace" is conflicting with the previous report that a partial explant of the pump segment of the catheter was revised).It was indicated that the patient had had no relief since it was replaced and that she was experiencing zero results so the patient had to assume there was a difficulty or malfunction ¿somewhere.¿ the patient had been getting increases in the dosage but it didn¿t make a difference and the patient wasn¿t feeling the effects of the boluses even though the personal therapy manager (ptm) said she got the bolus.It was also reported that the pump was giving the patient significant pain in the pump pocket.It was stated that the patient was becoming skeptical about the pump being able to perform at this point, per the consumer.It was indicated that the patient would see her managing healthcare professional (hcp) for follow-up on (b)(6) 2017.It was noted that a manufacturer¿s representative was at the last catheter revision surgery on (b)(6) 2017.The representative called the patient back on the direct dial line and it was reviewed that the patient was redirected to their hcp to discuss concerns since the catheter revision surgery.Note that this report that the patient had no relief since it was replaced is conflicting with the previous report that the issue was resolved and the patient status was alive with no injury.It was noted that the patient had a preexisting closed head injury and memory issues because of that.
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: 6305589
• Report Number: 3004209178-2017-02660
• Device Sequence Number: 565281
• Product Code: LKK
• UDI-Device Identifier: 00613994555595
• UDI-Public: 00613994555595
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2017

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: 11/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2017
• Supplement Date Received by Manufacturer: Not provided; 01/16/2017
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 02/09/2017; 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: 66 YR