MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION; SPINAL CORD STIMULATOR

Model Number SC-1110-02

Device Problems Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 06/07/2017

Event Type  Injury  

Event Description

A report was received that the patient was experiencing pain at the ipg site.The patient will undergo an ipg replacement procedure.

Manufacturer Narrative

Additional information was received that the patient's pocket pain was due to fall.No device malfunction was suspected.

Event Description

A report was received that the patient was experiencing pain at the ipg site.The patient will undergo an ipg replacement procedure.

Manufacturer Narrative

Additional information was received that the falls were not device related.

Event Description

A report was received that the patient was experiencing pain at the ipg site.The patient will undergo an ipg replacement procedure.

Manufacturer Narrative

Additional information was received that the patient underwent an ipg replacement procedure.Device malfunction was suspected.The patient was doing well postoperatively.

Event Description

A report was received that the patient was experiencing pain at the ipg site.The patient will undergo an ipg replacement procedure.

Manufacturer Narrative

Add'l information was received that the patient underwent a revision procedure wherein the ipg and one of the leads were replaced.Device malfunction was suspected.The patient was doing well postoperatively.Additional suspect medical device component involved in the event: model #: sc-2218-70 serial #: (b)(4) description: linear st lead, 70cm sc-1110-02 (sn: (b)(4)) device evaluation indicated that the source of pocket pain could not be determined.Current leakage tests verified no loss of electric current.Residual gas analysis verified that the device insulation was not compromised.Review of the sterilization record did not find any anomalies or deviations that potentially relate to the reported event.The device passed the required test and revealed normal device characteristics.Sc-2218-70 (sn: (b)(4)) device evaluation indicated that the visual inspection of the lead found a fractured spacer between contact # 8 and retention sleeve.Review of the sterilization record did not find any anomalies or deviations that potentially relate to the reported event.Sc-2218-50 (sn: (b)(4)) device evaluation indicated that the complaint of high impedance has been confirmed.Visual inspection found lead body was bent or kinked or damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location is 19 cm from the distal end.X-ray inspection confirmed 2 cables were fractured (electrodes 2, 6).There are no exposed cables at the clik site fracture.The fractured cables resulted in the reported high impedances.Review of the sterilization record did not find any anomalies or deviations that potentially relate to the reported event.

Event Description

A report was received that the patient was experiencing pain at the ipg site.The patient will undergo an ipg replacement procedure.

• Brand Name: PRECISION
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 6668905
• MDR Text Key: 78441468
• Report Number: 3006630150-2017-02357
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767688
• UDI-Public: (01)08714729767688(17)121001(10)13838958
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/07/2017

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2012
• Device Model Number: SC-1110-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 06/26/2017
• Supplement Dates Manufacturer Received: 06/28/2017; 07/27/2017; 09/08/2017; 10/31/2017
• Supplement Dates FDA Received: 07/20/2017; 08/15/2017; 09/26/2017; 10/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2010
• 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: 57 YR