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

Model Number	ADDR06
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Muscle Stimulation (1412)
Date of Event	04/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 507652 lead, implanted: (b)(6) 2009.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient experienced pocket stimulation after a device change out.It was also noted that the device was implanted sub-muscular which would likely have been the cause of the new pocket stimulation.Reprogramming was performed which significantly decreased the stimulation.The implantable pulse generator (ipg) remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: ADAPTA DR
• 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: 7514582
• Report Number: 3004209178-2018-10919
• Device Sequence Number: 1524323
• Product Code: NVZ
• UDI-Device Identifier: 00643169708662
• UDI-Public: 00643169708662
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2018

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: 12/14/2018
• Device Model Number: ADDR06
• Device Catalogue Number: ADDR06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 05/15/2018
• 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: 695758 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR