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

Model Number	ADSR01
Medical Device Problem Codes	Failure to Capture (1081); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2018
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 a lead revision procedure was done to replace the right ventricular (rv) lead which exhibited high thresholds.The following day, it was noted there was no capture observed on the device, and an x-ray revealed that a new lead had not been fully inserted into the header.The patient was brought back to the operating room, and the lead was re-inserted into the device header.All measurements tested normal, and the issue was resolved.The implantable pulse generator (ipg) remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ADAPTA SR
• 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: 7541576
• Report Number: 3008973940-2018-01208
• Device Sequence Number: 2512313
• Product Code: NVZ
• UDI-Device Identifier: 00643169709041
• UDI-Public: 00643169709041
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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: 04/28/2019
• Device Model Number: ADSR01
• Device Catalogue Number: ADSR01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 05/29/2018
• 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: 511211 BOSTON SCI LEAD X 2
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR