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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ADAPTA DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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MEDTRONIC PUERTO RICO OPERATIONS CO. ADAPTA DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number ADDR03
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Hematoma (1884)
Date of Event 03/28/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 4266 lea,d implanted: unknown.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient presented with a pocket hematoma.The pocket was revised and the patient's implantable pulse generator remains in use.No further patient complications have been reported as a result of this event.
 
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Brand Name
ADAPTA DR
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 Key8544972
Report Number3004209178-2019-08155
Device Sequence Number19443962
Product Code NVZ
UDI-Device Identifier00643169474154
UDI-Public00643169474154
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
P980035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/24/2019
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? No
Operator of Device Lay User/Patient
Device Expiration Date07/28/2020
Device Model NumberADDR03
Device Catalogue NumberADDR03
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/28/2019
Initial Report FDA Received Date04/24/2019
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
4269 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age78 YR
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