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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 Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964); Insufficient Information (3190)
Patient Problems Fall (1848); Muscular Rigidity (1968); Therapeutic Response, Decreased (2271)
Event Date 06/01/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id neu_unknown_cath, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
On 2018-aug-28, information was received from a manufacturer representative (rep) regarding a patient receiving baclofen (unknown do se and concentration) via an implantable pump for an unknown indication for use. On (b)(6) 2018, a catheter issue occurred and the patient experienced loss of therapy. A dye study was performed but no further information regarding the dye study was reported. The issue was not resolved at the time of this report. Surgical intervention was planned, but not scheduled. The patient's status was alive - no injury.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp) on 01-oct-2018 who reported that the patient¿s loss of therapy began in approximately (b)(6) 2018. The catheter was determined to be occluded. A revision surgery was scheduled for (b)(6) 2018 at which time they planned to revise the catheter without explanting the pump. The indication for pump use was spinal cord injury/spinal cord disease and intractable spasticity. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on 04-oct-2018 from the patient who reported that her spasticity was really bad, so bad that she fell off her chair. Per the patient, they did a lot of tests and found out that the catheter was ¿clogged or plugged¿. They stuck a needle in to see what was wrong and they could not pull out ¿residue¿. She was having surgery on (b)(6) 2018 because they may need to replace the catheter so the medicine could actually work. No further complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare provider who reported that there was no pump problem. The catheter did not appear to work with dye study. Per the physician, at surgery (b)(64) 2018 the catheter and pump worked normally. The pump was not replaced. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Per the physician, at surgery (b)(6) 2018 the catheter and pump worked normally; and not per the physician, at surgery (b)(6) 2018 the catheter and pump worked normally as previously reported. 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 MN 00777 1200
MDR Report Key7830946
MDR Text Key118711198
Report Number3007566237-2018-02580
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2018
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/07/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/29/2018 Patient Sequence Number: 1
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