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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA QUAD CRTP 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 Cellulitis (1768); Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling (2091); Fluid Discharge (2686)
Event Date 08/07/2017
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 459888 lead, implanted: (b)(6) 2017; 5076-52 lead, implanted: (b)(6) 2017. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that within a few weeks post-implant, the patient was referred to the emergency department due to swelling around the implant site, with clear yellow fluid and mild redness over the wound. Mild erythema was seen over the wound edges, with a small amount of yellow exudate from the wound. Some fluctuance under and around the wound was noted but no warmth or surrounding redness other than at the edges. Minimal tenderness was noted over the wound. The patient also experienced pain. A superficial incisional surgical site infection was noted, with cellulitis of the chest wall. The patient was prescribed antibiotics, and the device remains in use. The event was noted to be procedure-related by a study investigator. No further patient complications have been reported as a result of this event. The patient is a participant in the post approval clinical surveillance product surveillance registry.
 
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Brand NamePERCEPTA QUAD 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 Key7633573
MDR Text Key112159744
Report Number3004209178-2018-14187
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
Report Date 06/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/14/2018
Device Model NumberW4TR01
Device Catalogue NumberW4TR01
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 Received05/29/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/21/2017
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: 06/25/2018 Patient Sequence Number: 1
Treatment
383069 LEAD
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