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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Pocket Erosion (2013); Rash (2033); Local Reaction (2035); Skin Inflammation (2443); Test Result (2695)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare provider (hcp) via a manufacturer's representative regarding a patient who was receiving baclofen (unknown concentration and dose) via an implantable pump for an unknown indication for use. It was stated there was dermatitis caused by an implanted pump. The event date was unknown. The event occurred during post-op. This was apparently an allergic reaction resulting in dermatitis. The location was superficial in the device pocket. The patient had an allergic reaction before, the pocket site was changed, and the patient again developed the allergic reaction. It was stated that no actions had been taken so far; the doctors were evaluating what to do. Medical or surgical intervention was not needed to prevent permanent impairment of a function. The pump remained implanted and in service. It was unknown if the event lead to or extended hospitalization. Contributing factors to the event were not known. It was stated there was permanent injury, and the patient status was alive with injury. Specification of this injury was dermatitis in the zone of implant. The issue was not resolved. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer's representative on (b)(6)2018. It was reported that "doctors couldn't determine the exact cause of the dermatitis and offered the patient to either explant or treat the dermatitis for life and the patient chose the first option. " it was also reported that the pump would not be explanted/replaced (this is conflicting with the report the patient chose to explant).
 
Manufacturer Narrative
Due to imdrf harmonization, conclusion code 92 no longer applies. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported that the clinical picture and examinations carried out were highly compatible with an erythema ab igne attributable to the implanted device. It was stated that however, given that the patient's base frame had been totally solved with the pump, an aggressive scheme was being used from the local point of view, which to date had made the table stationary and controlled and that therefore, for now, the removal of the device has been rejected.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received indicated that the actual diagnosis of the skin condition was ab igne that was maybe due to the pump since the patient hadn't been exposed to other heat sources. The location of the reaction and reappearance in relation to the implanted device was described as dermatitis overlying the area where the pump was implanted. No pictures were available. The conditions had not been resolved as of 2018-dec-13. The patient had been treated with topical medication but with not significant results.
 
Manufacturer Narrative
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. Pump interrogation at medtronic return product analysis lab indicated the pump was delivering baclofen [2,000. 0 mcg/ml] at a dose of 145. 1 mcg/day. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The returned device passed all testing in the laboratory and no anomalies were identified. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Patient code (b)(4) does not apply. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received via follow-up. It was reported that the patient was not exposed to an mri or any other procedure or source that would have generated a large amount of radio frequency (rf) energy or electromagnetic interference (emi) to the pump pocket area. The patient also reportedly had not been using a heating pad, hot water bottle, heated blanket or other external heat sources. A patch test was done which did not result in allergies to pump components. The erythema ab igne diagnosis was made by a dermatologist based on the clinic and the result of the biopsy (psoriasiform dermatitis with spongiosis and eosinophils). It was also related that the site of the original skin affected with dermatitis improved with remission of the dermatitis after the change of position of the pump (which occurred on (b)(6) 2018) leaving only residual hyperpigmentation. Then the new site began alterations after four months and as of (b)(6) 2019, the skin of the second site was still under treatment. The pump was explanted on (b)(6) 2018. The reason for explant was reported as that the pump was exposed through a segment of friable skin affected by the dermatitis. It was noted that these answers provided were from the treating doctor along with a multidisciplinary team of two neurosurgeons and a dermatologist.
 
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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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7428993
MDR Text Key105410205
Report Number3004209178-2018-07971
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/14/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/16/2014
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: 04/13/2018 Patient Sequence Number: 1
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