MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADVISA DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	A4DR01
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 device longevity was lower than expected given the low outputs that the ipg had been programmed.The ipg was explanted and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.The actual longevity was less than 80% of the 99.9% longevity limit.The device failed longevity (77.68%).Hybrid analysis found nominal current drain.Without the history of the programmed settings throughout its service life, there is no way to determine why the longevity did not match the predicted model.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ADVISA DR
• 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 Key: 6920401
• Report Number: 3004209178-2017-20851
• Device Sequence Number: 16356886
• Product Code: NVZ
• UDI-Device Identifier: 00643169050730
• UDI-Public: 00643169050730
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/14/2013
• Device Model Number: A4DR01
• Device Catalogue Number: A4DR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1388T LEAD, 1346T LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR