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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

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MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W1TR01
Device Problems Nonstandard Device (1420); Pocket Stimulation (1463); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Death (1802); Unspecified Infection (1930); Pocket Erosion (2013); Sepsis (2067)
Event Date 06/25/2018
Event Type  Death  
Manufacturer Narrative
Concomitant medical products: 4968-35 lead implanted: (b)(6) 2018. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient developed pocket erosion and infection. The cardiac resynchronization therapy pacemaker (crt-p) was removed, the intravenous leads were removed and the existing epicardial left ventricular (lv) lead was tunneled out below the pocket and connected to the externalized crt-pt to provide temporary pacing support during antibiotic and wound therapy. The epicardial lead and crt-p will be replaced at a later date. No further patient 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, which indicated the patient passed away approximately 6 weeks later due to sepsis.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePERCEPTA CRTP
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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7707545
MDR Text Key114614916
Report Number3004209178-2018-16334
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
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/28/2018
Device Model NumberW1TR01
Device Catalogue NumberW1TR01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2412-2018

Patient Treatment Data
Date Received: 07/20/2018 Patient Sequence Number: 1
Treatment
5076-52 LEAD, 5076-45 LEAD
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