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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 ADDR06
Medical Device Problem Code Migration or Expulsion of Device (1395)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/10/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical product: 502358 lead, implant date: (b)(6) 1990.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported by the patient's representative that "it rides a little bit low, the pacemaker.It's kind of flipped since it was placed there, and it's really low".The implantable pulse generator (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 Key10476086
Report Number3004209178-2020-15108
Device Sequence Number3092262
Product Code NVZ
UDI-Device Identifier00613994222077
UDI-Public00613994222077
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P980035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/01/2020
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 Lay User/Patient
Device Expiration Date10/28/2016
Device Model NumberADDR06
Device Catalogue NumberADDR06
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/10/2020
Initial Report FDA Received Date09/01/2020
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
5076-45 LEAD.
Patient Age64 YR
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