MAUDE Adverse Event Report: MPRI EXTENSION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	3708240
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other applicable components are: product id: 3550-06, serial# unknown, product type: accessory.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) regarding a patient with an implantable neurostimulator (ins) via a manufacturer representative.It was reported that the extension carrier of the extension stylet broke off.It was reported that it was extremely difficult to pass the tunneler in the neck area because it was very tight.The surgeon pulled really hard and a piece of the tunneler broke off and was stuck in the neck along the path of the passer.The surgeon had to make an incision in the neck to find the extension connector and remove the piece of plastic from the tunneler.The surgeon then retunneled a little bit to get the connector to the correct spot.Additional information was received from a manufacturer representative (rep).It was clarified that the piece that broke off was the plastic piece that hold the last carrier of the extension.The manufacturer representative suspected that the tunneler got caught on tissue along the track.No symptoms or complications were reported.

• Brand Name: EXTENSION
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8739223
• Report Number: 2649622-2019-11050
• Device Sequence Number: 2040481
• Product Code: LGW
• UDI-Device Identifier: 00643169272996
• UDI-Public: 00643169272996
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2019
• Device Model Number: 3708240
• Device Catalogue Number: 3708240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR