MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-1132

Device Problems Charging Problem (2892); Wireless Communication Problem (3283)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: exact date unknown, event occurred (b)(6) 2020.

Event Description

It was reported that the patients ipg was unable to take a charge and was having difficulty communicating with the remote control (rc).The patient was given multiple chargers and rcs to attempt to charge the ipg, however, it was unsuccessful.The patient underwent an explant procedure wherein only the ipg and one tail of the paddle lead were removed.It was noted that during the explant procedure, the tail was not released from the locking mechanism.

Manufacturer Narrative

Sc-1132.Sn: (b)(6).The returned ipg was analyzed and it was found that the ipg header was altered or damaged during the explant procedure.The damage was not considered a failure.The reported event was not confirmed.The ipg was charged fully from its hibernation and regained its functionality after being charged.

Event Description

It was reported that the patients ipg was unable to take a charge and was having difficulty communicating with the remote control (rc).The patient was given multiple chargers and rcs to attempt to charge the ipg, however, it was unsuccessful.The patient underwent an explant procedure wherein only the ipg and one tail of the paddle lead were removed.It was noted that during the explant procedure, the tail was not released from the locking mechanism.

• Brand Name: PRECISION SPECTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12533015
• MDR Text Key: 273341523
• Report Number: 3006630150-2021-05422
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• UDI-Public: 08714729821526
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/03/2019
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 20107329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male