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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Patient Problem Scar Tissue (2060)
Event Date 12/28/2021
Event Type  Injury  
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider (hcp)) regarding a patient who was receiving morphine drug, unknown (1000mcg/ml at 75mcg/day) via an implantable pump for spinal pain. It was reported that during surgery the catheter was placed without issue but it was noted that there was no cerebrospinal fluid (csf) flow from the tip of the catheter. The hcp was concerned that the extra scar tissue could be causing a possible kink in the catheter. An attempt was made to replace the anchor, but then upon x-ray-the catheter tip had moved below level of where the hcp wanted it to be. The spinal segment and anchor were replaced and csf flow was then present as expected.
 
Manufacturer Narrative
Concomitant medical products: product id: 8780, lot# : hg44jpj05, implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 26-feb-2022, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
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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 Key13167791
MDR Text Key283241251
Report Number3004209178-2022-00111
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 01/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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