MAUDE Adverse Event Report: ST. JUDE MEDICAL / ABBOTT LABORATORIES PENTA TUNNELER; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Device Problems Material Separation (1562); Component Missing (2306); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2019

Event Type  malfunction  

Event Description

During use of sjm/abbott penta tunneler, it was noted that an approximate 2 inch long piece of the plastic sheath was missing.Patient incision was explored but plastic not found.It appears the 2 inch section of the plastic sheath separated and dislodged from the remainder of the plastic sheath during use of the device per manufacturer¿s instructions.

• Brand Name: PENTA TUNNELER
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): ST. JUDE MEDICAL / ABBOTT LABORATORIES
• MDR Report Key: 8301368
• MDR Text Key: 135744790
• Report Number: MW5083661
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/23/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR