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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ADAPTA SR; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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MEDTRONIC PUERTO RICO OPERATIONS CO. ADAPTA SR; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number ADSR03
Medical Device Problem Code Unstable Capture Threshold (3269)
Health Effect - Clinical Code Syncope (1610)
Date of Event 11/06/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient experienced syncope.The implantable pulse generator (ipg) device exhibited variations in capture management.Output was increased.The device remains in use.No further 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 PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key7256233
Report Number3004209178-2018-02700
Device Sequence Number1066305
Product Code NVZ
UDI-Device Identifier00613994222176
UDI-Public00613994222176
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P980035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/08/2018
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
Operator of Device Lay User/Patient
Device Expiration Date07/14/2017
Device Model NumberADSR03
Device Catalogue NumberADSR03
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/06/2017
Initial Report FDA Received Date02/08/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Life Threatening; Required Intervention;
Patient Weight80
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