MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADAPTA SR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	ADSR06
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	09/13/2018
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 patient received cardiopulmonary resuscitation.Upon implantable pulse generator (ipg) interrogation, there was noted ventricular tachycardia (vt) degraded to ventricular fibrillation (vf), but electromagnetic interference could not be ruled out.It was also reported that there was undersensing on the right ventricular (rv) lead.The ipg and rv lead remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: ADAPTA SR
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 7961417
• Report Number: 3004209178-2018-22933
• Device Sequence Number: 16537042
• Product Code: NVZ
• UDI-Device Identifier: 00613994222190
• UDI-Public: 00613994222190
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2018

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: Lay User/Patient
• Device Expiration Date: 02/14/2012
• Device Model Number: ADSR06
• Device Catalogue Number: ADSR06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR