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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ADAPTA; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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MEDTRONIC PUERTO RICO OPERATIONS CO. ADAPTA; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number ADSR06
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/17/2020
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 during the implantable pulse generator (ipg) implant procedure, the incumbent chronic pacing lead was not fully in the implantable pulse generator (ipg) header.The pacing lead was disconnected and reconnected.The ipg 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 PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key10419647
Report Number3004209178-2020-14240
Device Sequence Number14468135
Product Code NVZ
UDI-Device Identifier00643169708860
UDI-Public00643169708860
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P980035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/18/2020
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 Health Professional
Device Expiration Date11/28/2020
Device Model NumberADSR06
Device Catalogue NumberADSR06
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/27/2020
Initial Report FDA Received Date08/18/2020
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
PACESETTER LEAD.
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