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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 ADSR01
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/12/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product analysis: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the implantable pulse generator (ipg) system was explanted and replaced due to an infection.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 Key7412038
Report Number3004209178-2018-06880
Device Sequence Number1373329
Product Code NVZ
UDI-Device Identifier00643169474208
UDI-Public00643169474208
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P980035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/10/2018
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? No
Operator of Device Lay User/Patient
Device Expiration Date01/14/2018
Device Model NumberADSR01
Device Catalogue NumberADSR01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/12/2018
Initial Report FDA Received Date04/10/2018
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
407652 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age60 YR
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