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

Model Number 8637-40

Device Problem Kinked (1339)

Patient Problem Muscular Rigidity (1968)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: product id: neu_unknown_cath, lot# unknown, implanted: unknown , product type: catheter. Information references the main component of the system. Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown, ubd: unknown, udi#: unknown. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care professional (hcp) and representative regarding a patient in (b)(6). The medication, concentration, and dose via an implantable pump at the time of this event was not reported. The indication for use was not provided. It was reported that the patient¿s catheter was kinked as diagnosed via a revision in (b)(6) of 2018. The ¿kink was taken out¿ at the procedure. Currently, the physician inquired about how to confirm whether a pump was flipped or not. The "tip" or top of the pump was facing medial rather than superior. The patient had claimed to flip their pump back over manually. Troubleshooting was discussed. There were no symptoms reported. No further complications were reported/anticipated. Additional information was requested to determine the relationship potential pump flipping with the previous catheter kink.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Please note similar information had been previously reported in regards to the pump flipping and had already been captured in manufacturing report # 3004209178-2018-10822. Any further information pertaining to the (b)(6) 2018 pump flipping will solely be captured in that event. Going forward this event will solely capture the(b)(6)2018 catheter kink revision and includes: it was reported that the patient¿s catheter was kinked as diagnosed via a revision in (b)(6) of 2018. The ¿kink was taken out¿ at the procedure. In regards to the kink being taken out, the physician had opened in the back and exposed the catheter and disconnect the 2 pieces and was able to get cerebrospinal fluid (csf) flow form the distal catheter. As now reported, nothing was removed. The patient experienced increased spasticity which is why the physician operated on the patient. It was further reported that the catheter model and serial/lot, implant date of the catheter, and the cause of the catheter kink were all unknown. Continued efforts were being made to attempt further information from the physician, but nothing further to date was received. No further complications were reported/anticipated.

• 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: 7511486
• MDR Text Key: 108168187
• Report Number: 3004209178-2018-10826
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 07/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/14/2018 Patient Sequence Number: 1