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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ATTAIN OTW; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
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MPRI ATTAIN OTW; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE Back to Search Results
Model Number 419378
Medical Device Problem Code Positioning Problem (3009)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/24/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant products: d224trk device; implanted: (b)(6) 2012.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the left ventricular (lv) lead was not functioning as a lv lead and it was suspected the lead had moved.The lead was capped and replaced.No patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN OTW
Common Device Name
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key6711359
Report Number2649622-2017-07625
Device Sequence Number1491378
Product Code LWP
UDI-Device Identifier00885074200729
UDI-Public00885074200729
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
P010015
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/24/2017
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? Yes
Operator of Device Lay User/Patient
Device Expiration Date11/13/2008
Device Model Number419378
Device Catalogue Number419378
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/24/2017
Initial Report FDA Received Date07/13/2017
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
6947-58 LEAD, 5076-45 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age75 YR
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