• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problem Infusion or Flow Problem (2964)
Patient Problems Wound Dehiscence (1154); Muscular Rigidity (1968)
Event Date 06/17/2022
Event Type  Injury  
Event Description
Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving gablofen (1000 mcg/ml at 362 mcg/day) via an implanted pump. It was reported that the patient was admitted to the hospital with return of spasticity. A cap (catheter access port) study was done on (b)(6) 2022 and the physician was unable to withdraw csf (cerebrospinal fluid). The patient was taken to surgery the next day for a full pump/catheter revision. The hcp replaced the catheter due to its age. The pump was also replaced. The pump was functioning (no alarms/the logs were clear), however, there was a small area along the scar on the pump pocket that had an open wound. As a precautionary measure, the new pump was implanted at a different site. It was noted that there were no environmental, external, or patient factors that may have led or contributed to the issue, and it was indicated that the hcp had no further information to provide regarding the event. Following the procedure, the pump dose in the new pump was reduced to 150 mcg/day.
 
Manufacturer Narrative
Concomitant medical products: product id 8703, lot# j93117819, implanted: (b)(6) 1993, product type catheter. Product id 8596, lot/serial# (b)(4), implanted: (b)(6) 2006, product type catheter. Other relevant device(s) are: product id: 8703, serial/lot #: (b)(4), udi#: (b)(4) ; product id: 8596, serial/lot #: (b)(4), ubd: 28-sep-2006, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key14785641
MDR Text Key294564010
Report Number3004209178-2022-08018
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/14/2020
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/17/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/24/2018
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: 06/23/2022 Patient Sequence Number: 1
-
-