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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 8637-40
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2022
Event Type  malfunction  
Event Description
Information was received from multiple sources (manufacturer representative (rep), healthcare provider (hcp)) regarding a patient who was receiving baclofen (2000 mcg/ml at 240 mcg/day) via an implantable pump for intractable spasticity. It was reported that during a routine eri (elective replacement indicator) pump replacement, it came to the surgical team¿s attention that the catheter was severed. There were no known factors that may have led or contributed to the issue. The catheter was replaced and the issue was resolved at the time of report. The patient's medical history was asked but unknown. The patient's status at the time of report was alive, no injury.
 
Manufacturer Narrative
Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2022, product type catheter. Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 10-dec-2016, 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 Key14138181
MDR Text Key290068350
Report Number3004209178-2022-04896
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,Followup
Report Date 06/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2016
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/02/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/16/2015
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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