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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ADVISA MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. ADVISA MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number A2DR01
Device Problems Under-Sensing (1661); Decreased Sensitivity (2534)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that both the implantable pulse generator (ipg) and right ventricular (rv) his bundle lead exhibited intermittent un der-sensing, with low r-wave amplitude.Diagnostic testing/troubleshooting was performed and both the ipg and rv his bundle lead were reprogrammed and remain in use.No patient complications have been reported as a result of this event.
 
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Brand Name
ADVISA MRI SURESCAN
Type of Device
PULSE GENERATOR, PERMANENT, IMPLANTABLE
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 Key12047688
MDR Text Key257713020
Report Number3004209178-2021-09782
Device Sequence Number1
Product Code NVZ
UDI-Device Identifier00643169493377
UDI-Public00643169493377
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P980035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/28/2018
Device Model NumberA2DR01
Device Catalogue NumberA2DR01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/27/2021
Initial Date FDA Received06/23/2021
Date Device Manufactured07/05/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
383069 LEAD, 5076-52 LEAD
Patient Outcome(s) Required Intervention;
Patient Age68 YR
Patient Weight93
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