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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA QUAD CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

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MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA QUAD CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W4TR01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Inflammation (1932); Skin Erosion (2075)
Event Date 09/19/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: evolutpro-29-us transcatheter valve, implanted (b)(6) 2017. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that there was serious drainage from the cardiac resynchronization therapy pacemaker (crt-p) incision site approximately two months post-implant. The lateral edge of the incision had evidence of inflammation and the physician questioned whether it was related to a stitch abscess or a low grade infection. Cultures tested positive for serratia and the patient was placed on antibiotics for several weeks. The incision appeared to have healed at a follow-up appointment approximately one month later, with no drainage or redness seen. At a subsequent appointment approximately two weeks later, a small opening was noted along the incision line. The opening was reported to have closed or healed over the following week. The patient experienced tenderness at the implant site. The patient was seen by an allergist who felt that there was no reason to test for allergies after examining the pocket. They felt the issue was directly related to the serratia infection. The patient also experienced skin erosion. The crt-p system was removed and a leadless implantable pulse generator (ipg) was implanted. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the device was returned and analyzed. Returned product analysis was performed and no anomalies were found. If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePERCEPTA QUAD CRT-P MRI SURESCAN
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key9423139
MDR Text Key169530733
Report Number3004209178-2019-23229
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/28/2020
Device Model NumberW4TR01
Device Catalogue NumberW4TR01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2019
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: 12/06/2019 Patient Sequence Number: 1
Treatment
5076-52 LEAD, 459888 LEAD, 6725 ADAPTOR
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