MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ADAPTA; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	ADSR01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pocket Erosion (2013)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
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 patient preparation for an unrelated pocket revision, pocket erosion was noted exposing approximately half of the device.The implantable pulse generator (ipg) and right ventricular (rv) lead were explanted and later replaced with a leadless implantable pulse generator (ipg).No further patient complications have been reported as a result of this event.

• 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 Key: 10506742
• Report Number: 3004209178-2020-15562
• Device Sequence Number: 3134856
• Product Code: NVZ
• UDI-Device Identifier: 00643169708808
• UDI-Public: 00643169708808
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/28/2021
• Device Model Number: ADSR01
• Device Catalogue Number: ADSR01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/09/2020
• 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: 5076-52 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 91