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

Model Number 8637-40

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2022

Event Type  Injury  

Event Description

Information was received from multiple sources (healthcare provider, foreign, clinical study) regarding a patient who was receiving clonidine (200 mcg at 60. 04235 mcg/day) via an implantable pump. It was reported that the device diagnosis was catheter break/cut. The clinical diagnosis was indicated as not applicable.    during the procedure on (b)(6) 2022 the catheter had to be cut and repaired.   the surgeon had to cut the catheter and reconnected with an anchor.   the event was resolved without sequela as of (b)(6) 2022. Regarding etiology, the relationship of the event to both the device/therapy and implant procedure was related.

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath, serial#/lot#: unknown, product type: catheter. 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.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14375586
• MDR Text Key: 291507764
• Report Number: 3004209178-2022-06129
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/23/2015
• 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: 05/12/2022 Patient Sequence Number: 1