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

Model Number	ADSR01
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Mechanical Problem (1384); Capturing Problem (2891)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
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 implant of the implantable pulse generator (ipg) was unsuccessful because the set screw would not secure the right ventricular (rv) lead.The unsecured rv lead exhibited intermittent capture with the ipg.The ipg was explanted and replaced.After the ipg replacement, the rv lead continued to exhibited no capture and the lead also exhibited high and unstable thresholds.It was noted that the patient experienced bradycardia due to the rv lead capture issues.The rv lead was capped and replaced.No further 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.The returned device had foreign material in the connector, indicated a damaged grommet and indicated a missing set screw.It was noted the connector was damaged and there was grommet/setscrew damage.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: 7255078
• Report Number: 3008973940-2018-00126
• Device Sequence Number: 16383063
• Product Code: NVZ
• UDI-Device Identifier: 00643169709041
• UDI-Public: 00643169709041
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 04/25/2018

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: Physician
• Device Expiration Date: 03/28/2019
• Device Model Number: ADSR01
• Device Catalogue Number: ADSR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR