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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 Material Integrity Problem (2978); Positioning Problem (3009); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/05/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial# (b)(4), product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 18-mar-2023, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving lioresal (baclofen) (500 mcg/ml at 25 mcg/day) via an implantable infusion pump. It was reported that during the initial catheter implant, the physician had trouble placing the catheter because it was curling up in the intrathecal space and would not go up to t2. The physician did try to straighten the catheter and tried several times to get the catheter tip to t2; however, after several attempts and feeling like they had moved the guidewire within the catheter and was afraid of shearing (micro tears) in the catheter, the physician decided that they wanted a new catheter and entered at a different level and angle. The physician stated that the catheter curling may have been due to scar tissues or the patient's anatomy; however, was not sure what it was.  there were no signs or symptoms reported. The issue was resolved at the time of report. The patient's medical history included spasticity due to amyotrophic lateral sclerosis (als). The patient's status at the time of report was alive - no injury.
 
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial# (b)(4), product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 18-mar-2023, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving lioresal (baclofen) (500 mcg/ml at 25 mcg/day) via an implantable infusion pump. It was reported that during the initial catheter implant, the physician had trouble placing the catheter because it was curling up in the intrathecal space and would not go up to t2. The physician did try to straighten the catheter and tried several times to get the catheter tip to t2; however, after several attempts and feeling like they had moved the guidewire within the catheter and was afraid of shearing (micro tears) in the catheter, the physician decided that they wanted a new catheter and entered at a different level and angle. The physician stated that the catheter curling may have been due to scar tissues or the patient's anatomy; however, was not sure what it was.  there were no signs or symptoms reported. The issue was resolved at the time of report. The patient's medical history included spasticity due to amyotrophic lateral sclerosis (als). The patient's status at the time of report was alive - no injury.
 
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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 Key12783506
MDR Text Key285162649
Report Number3004209178-2021-16731
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 11/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2021
Is this an Adverse Event Report? No
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 Received11/05/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/23/2021
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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