MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PROTECTA DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	D334DRM
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: 6947m62 lead, implanted: (b)(6) 2012.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a routine implantable cardioverter defibrillator (icd) replacement the set screw was very difficult to get out.The wrench would not engage the screw.The physician was able to finally engage the set screw but it came out of the device.The device was replaced and no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTECTA DR
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• 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: 8797806
• Report Number: 3004209178-2019-13675
• Device Sequence Number: 3026971
• Product Code: LWS
• UDI-Device Identifier: 00613994714602
• UDI-Public: 00613994714602
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2019

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 Date: 07/14/2013
• Device Model Number: D334DRM
• Device Catalogue Number: D334DRM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/19/2019
• 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
• Patient Age: 83 YR