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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADAPTA; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADAPTA; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number ADDR03
Medical Device Problem Codes Signal Artifact/Noise (1036); Electromagnetic Interference (1194)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/15/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 4260, lead implanted: (b)(6) 1990.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The patient reported that their implantable pulse generator (ipg) reset when they were near the metal detector in a store.The device remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
ADAPTA
Common Device Name
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key8877804
Report Number3004209178-2019-15291
Device Sequence Number2048102
Product Code NVZ
UDI-Device Identifier00613994222060
UDI-Public00613994222060
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
PMA/510(K) Number
P980035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/09/2019
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 Date08/14/2013
Device Model NumberADDR03
Device Catalogue NumberADDR03
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/15/2019
Initial Report FDA Received Date08/09/2019
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
5076-45 LEAD
Patient Age57 YR
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