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

Model Number	SESR01
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2017
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 due to an unspecified set screw issue.The ipg was explanted and replaced.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.The returned device had foreign material in the connector.The returned device had a damaged connector.The returned device indicated a grommet issue.The returned device indicated a damaged grommet.The returned device indicated foreign material on set screw.The returned device indicated a set screw with a rounded socket.The returned device indicated a damaged set screw.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SENSIA SR
• 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: 7530146
• Report Number: 3004209178-2018-11392
• Device Sequence Number: 16507151
• Product Code: NVZ
• UDI-Device Identifier: 00643169474260
• UDI-Public: 00643169474260
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: 06/14/2018
• Device Model Number: SESR01
• Device Catalogue Number: SESR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR