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

Model Number	ADSR01
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/31/2018
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
The patient reported that for the past two and a half weeks, they "have pain in the area and the device has moved out of place.I'm not getting much sleep because of it".In addition, the patient indicated that they went to the doctor's office, and was told "it was normal, the device hasn't moved but the scar tissue had".Follow-up investigation with the clinic revealed that the doctor chose to reposition the pacemaker in hopes of alleviating the patient's pain.The implantable pulse generator (ipg) remains 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7413866
• Report Number: 3004209178-2018-06976
• Device Sequence Number: 10995698
• Product Code: NVZ
• UDI-Device Identifier: 00643169474208
• UDI-Public: 00643169474208
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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: 05/28/2018
• Device Model Number: ADSR01
• Device Catalogue Number: ADSR01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 04/10/2018
• 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: 5076-45 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 29 YR