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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS ADAPTA SR; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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MEDTRONIC SINGAPORE OPERATIONS ADAPTA SR; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number ADSR01
Medical Device Problem Codes Failure to Interrogate (1332); Output Problem (3005)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/08/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that there were problems interrogating the implantable pulse generator (ipg) and some electrograms (egm) were not present.It was also reported that the left ventricular (lv) pacing lead exhibited out of range lead impedance that triggered a warning.The ipg and lv lead remain in use.No patient complications have been reported as a result of this event.
 
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Brand Name
ADAPTA SR
Common Device Name
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
MEDTRONIC SINGAPORE OPERATIONS
49 changi south avenue 2
nasaco tech centre
singapore 48605 6
SG  486056
MDR Report Key8253628
Report Number3008973940-2019-00098
Device Sequence Number1953559
Product Code NVZ
UDI-Device Identifier00643169709041
UDI-Public00643169709041
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
P980035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 01/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date03/28/2019
Device Model NumberADSR01
Device Catalogue NumberADSR01
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/19/2018
Initial Report FDA Received Date01/16/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
4965-25 LEAD
Patient Age7 YR
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