MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS MEDTRONIC PAIN PUMP DRUG INFUSION SYSTEM; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Pain (1994)

Event Date 09/28/2018

Event Type  Injury  

Event Description

Medtronic pain pump device discharged a shock internally causing pain for several hours.

• Brand Name: MEDTRONIC PAIN PUMP DRUG INFUSION SYSTEM
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
• MDR Report Key: 7926067
• MDR Text Key: 122503796
• Report Number: MW5080255
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/10/2020
• Device Model Number: 8637-20
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 84