MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS ADAPTA; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	ADSR01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Bradycardia (1751); Embolism (1829); Endocarditis (1834); Fever (1858); Hypoxia (1918); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Pulmonary Edema (2020); Staphylococcus Aureus (2058); Sepsis (2067); Heart Failure (2206); Respiratory Failure (2484); Exit Block (2628)
Date of Event	10/26/2018
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 the patient presented with vegetation, possible abscess formation, sepsis, (b)(6), acute respiratory failure with hypoxia, septic embolism, chronic systolic heart failure, endocarditis, lower back pain and generalized fevers.The patient developed ominous rhythms including symptomatic bradycardia, sinoatrial dysfunction and high atrioventricular block.The patient was treated with antibiotics.The single chamber implantable pulse generator (ipg) system was removed and a tricuspid valve replacement was performed.A temporary pacing right ventricular (rv) lead was placed.Over the ensuing week it was noted pus was emanating from the temporary lead with tenderness noted.The patient underwent debridement and flap closure.The patient developed hematoma which was subsequently evacuated.A computerized tomography (ct) of the chest showed indication of septic embolic disease and mild pulmonary edema with bibasilar atelectasis and diffuse body wall anasarca.The chest debridement showed focal necrotizing inflammation, fat necrosis and hemorrhage.The status of the temporary pacing lead is unknown.No further patient complications have been reported as a result of this e vent.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ADAPTA
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SG 486056
• MDR Report Key: 8806564
• Report Number: 3008973940-2019-02009
• Device Sequence Number: 13538792
• Product Code: NVZ
• UDI-Device Identifier: 00643169709041
• UDI-Public: 00643169709041
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019

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: 03/28/2019
• Device Model Number: ADSR01
• Device Catalogue Number: ADSR01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 08/08/2019
• 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: 5076-58 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 32 YR
• Patient Weight: 68