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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. AMPLIA MRI QUAD CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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MEDTRONIC PUERTO RICO OPERATIONS CO. AMPLIA MRI QUAD CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number DTMB1QQ
Device Problems Premature Discharge of Battery (1057); Fracture (1260); Nonstandard Device (1420); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917); Noise, Audible (3273)
Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 07/05/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient experienced inappropriate therapy caused by a fracture of the right ventricular (rv) lead.It was noted that the rv lead had oversensing with noise episodes and an rv lead alert due to high sensing integrity counter.It was further reported that the cardiac resynchronization therapy defibrillator (crt-d) had premature battery depletion due to excessive shocks to the patient.The lead was capped and replaced, and the device was explanted and replaced.No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
The device was returned and analyzed.Analysis of the device revealed normal battery depletion.The battery indicator signifying that it is time for device replacement occurred after explant.This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.The device is no longer included as part of the field action.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The device was returned and analyzed.Analysis of the device revealed normal battery depletion.The battery indicator signifying that it is time for device replacement occurred after explant.This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.The device is no longer included as part of the field action.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient experienced inappropriate therapy caused by a fracture of the right ventricular (rv) lead.It was noted that the rv lead had oversensing with noise episodes and an rv lead alert due to high sensing integrity counter.It was further reported that the cardiac resynchronization therapy defibrillator (crt-d) had premature battery depletion due to excessive shocks to the patient.The lead was capped and replaced, and the device was explanted and replaced.No further patient complications have been reported as a result of this event.
 
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Brand Name
AMPLIA MRI QUAD CRT-D
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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 Key7731950
MDR Text Key115410215
Report Number3004209178-2018-16933
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00643169543386
UDI-Public00643169543386
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
2 Patient was Involved in the Event
Date FDA Received07/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/14/2017
Device Model NumberDTMB1QQ
Device Catalogue NumberDTMB1QQ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0962-2017
Patient Sequence Number0
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age89 YR
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